Syner-G

Lead validation of equipment, utilities, and computerized systems in GMP environments, while managing validation lifecycles and mentoring junior staff. | Requires a bachelor's degree in life science or engineering, 7–11 years of relevant industry experience, and strong FDA cGMP, risk-based validation, and technical documentation expertise. | COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW We are seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members. KEY RESPONSIBILITIES (This list is not exhaustive and may be supplemented or adjusted as needed.) Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets. Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports. Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures. Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities. Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions. Lead P&ID walkdowns to verify installation, configuration, and system readiness. Perform and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes. Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation. Lead periodic reviews and requalification activities for temperature‑controlled systems and other validated assets. Provide technical mentorship and guidance to junior validation staff. Collaborate cross‑functionally to ensure validation activities align with project timelines and operational needs. QUALIFICATIONS AND REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education Bachelor’s degree in a life science, engineering, or related technical field. Technical Experience 7–11 years of experience in the biotech, pharmaceutical, or medical device industry. Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles. Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation. Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation. Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports. Experience supporting audits, regulatory inspections, and remediation activities. Knowledge, Skills, and Abilities Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences. Highly organized with strong documentation and analytical skills. Ability to lead validation workstreams, manage multiple priorities, and work independently. Strong problem‑solving skills and experience supporting investigations and root‑cause analysis. Ability to mentor junior engineers and contribute to team development. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $115,000 to $145,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Oversee project documentation and information workflows across engineering and construction workstreams, ensuring project information remains accurate and accessible throughout its lifecycle. | Requires a bachelor's degree in engineering, construction management, or a related field, hands-on Autodesk Forma experience, and construction documentation experience in a regulated environment. | COMPANY DESCRIPTION:  A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here [https://www.youtube.com/watch?v=2rUMvtncuw8].  Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.  At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.  For more information, visit www.Synergbiopharma.com [https://www.synergbiopharma.com/] POSITION OVERVIEW: We are seeking a Project Operations & Operational Excellence Lead to support a Design & Construction (D&C) Project Controls and Site Services organization for a major capital program. This role is focused on improving, standardizing, and scaling how the D&C organization operates, with documentation and information management serving as a major workstream within the broader operational excellence agenda. The individual will lead process improvement, governance, workflow standardization, and cross-functional operating-model improvements, while ensuring project information, documentation, and records are managed in a practical, consistent, and execution-focused way.  The ideal candidate brings strong experience leading operational excellence and/or process improvement efforts in complex capital project environments, supported by hands-on experience with documentation, information management, common data environments, and/or project controls interfaces.   This position is internally classified as a Sr. Project Coordinator and will have a primary focus on reliability engineering. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or adjusted as necessary.) * Lead operational excellence, project operations, and process improvement activities across D&C Project Controls and Site Services workstreams.  * Apply Lean, operational excellence, and continuous improvement methods to simplify workflows, reduce manual effort, clarify ownership, strengthen handoffs, improve visibility, and embed sustainable ways of working across project teams.  * Develop, standardize, establish, and sustain practical operating processes, workflows, governance routines, documentation standards, naming conventions, metadata practices, and information-management controls that support consistent project execution.  * Use documentation lifecycle management as a key operational workstream, ensuring creation, review, approval, issuance, revision, archival, and turnover practices are aligned with project execution needs.  * Can provide functional leadership and practical guidance for Autodesk Forma, Autodesk Construction Cloud, common data environment workflows, related documentation workflows, and project information management practices.  * Coordinate documentation and information exchange between engineering firms, construction contractors, vendors, project controls, commissioning, and site stakeholders.  * Develop and maintain operating metrics, document registers, transmittals, drawing/document logs, review cycles, status reporting, and workflow performance indicators that help leadership manage execution.  * Partner with Project Controls leadership and the Integrated Delivery Office to develop scalable documentation-management processes across the site/program.  * Provide guidance, coaching, and mentoring to document control, project support, and cross-functional personnel.    QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education: * Bachelor's degree in Engineering, Construction Management, Information Management, Business, or related field; equivalent experience may be considered.  Technical Experience: * 8–10+ years of experience in operational excellence, process improvement, project operations, project controls, information management, or related project delivery functions, with demonstrated experience designing and implementing improved ways of working across Design & Construction, Engineering, Construction Management, Facilities, Project Controls, or similar capital project organizations.  * Lean Six Sigma, Operational Excellence, project operations, or equivalent continuous improvement experience, with demonstrated ability to improve processes, standardize workflows, strengthen handoffs, clarify governance, and drive sustainable execution in complex project environments.   Knowledge, Skills, and Abilities:   * Strong understanding of project operations in facilities or capital projects environments, including how documentation systems, governance routines, project controls, planning, execution, turnover, and operational readiness processes connect.  * Strong working knowledge of construction and project documentation workflows, document lifecycle management, common data environments, and the role of information management in improving project execution, decision-making, and accountability.  * Experience coordinating operational workflows, documentation requirements, and information exchange across multiple internal and external stakeholders.   Preferred Qualifications:   * Operational Excellence and Project Operations lead who can diagnose how work gets done, design practical improvements, align stakeholders, and implement sustainable operating practices.  * Strong documentation and information-management experience, with facility working across Project Controls, Site Services, Engineering, Construction, contractors, and leadership teams to improve workflow clarity, governance, execution discipline, and visibility.  * Able to translate process gaps, documentation pain points, and information-flow issues into scalable standards, dashboards, routines, and tools that support project delivery.  * Experience within pharmaceutical, biotechnology, life sciences, or GMP-regulated environments.  * Experience supporting large-scale facility construction, expansion, retrofit, or manufacturing site programs.  * Experience with Autodesk Construction Cloud, Autodesk Forma, BIM/CDE environments, or other Autodesk information-management platforms.  * Familiarity with project controls processes including schedule, cost, change control, risk, reporting, documentation process integration, governance routines, and operational performance management.  * Experience supporting project turnover, commissioning, qualification, or operational readiness documentation.  * Experience developing operational procedures, SOPs, workflows, governance standards, document-management procedures, and information-management practices.  ESSENTIAL FUNCTIONS: Physical Demands:  The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.  Work Environment:  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.  TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $150,000 to $165,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.  LEGAL STATEMENT:   Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Lead facility teams and subcontractors, maintain building systems, and ensure facility operations meet client objectives and safety standards. | Requires 10+ years of facility management experience, 5 years leading teams, and a related bachelor's degree preferred. | COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: The Sr. Facilities Manager is responsible for the management and development of a team assigned to a building or group of buildings. This role focuses on meeting and exceeding operating goals, client objectives, and customer needs. The Sr. Facilities Manager will have daily interactions with clients, tenants, and subcontractors, and will contribute to the delivery of strategic and operational objectives through the maintenance, repair, and upgrade of facilities. This position ensures a safe, productive, and efficient working environment essential to business performance and company image. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) Demonstrate a strong commitment to safety excellence and promote safe behaviors Respond to after-hours calls and emergencies as needed Foster a positive work environment and promote teamwork Maintain thorough understanding of critical utilities, facilities, and building systems Support infrastructure renewal and replacement recommendations Develop scopes of work, solicit proposals, and recommend subcontractor awards Assist in building assessments and evaluations Manage a team of Facilities Technicians Oversee ordering and inventory of consumables Ensure compliance with safety rules, guidelines, and protocols Drive labor productivity and effective scheduling Lead by example with strong communication and leadership skills Train, develop, and monitor team performance Support talent succession planning Maintain professional communication with clients, tenants, and subcontractors Perform other duties as assigned QUALIFICATIONS AND REQUIREMENTS: Education: High school diploma or equivalent required Bachelor’s degree in Facilities Management, Engineering, Business Administration, or a related field preferred Technical Experience: Minimum of 10 years of experience in facility management Minimum of 5 years of experience leading teams of 5 or more Proven track record of managing and developing personnel within the facilities industry Demonstrated ability to manage client relationships and maintain long-term partnerships Experience coordinating operations and communicating across multiple levels of an organization Background in planning, prioritizing, and tracking work completion Experience in performance and quality monitoring of staff and subcontractors Familiarity with talent succession planning and employee development Knowledge, Skills and Abilities: Working knowledge of primary and critical utilities, including electrical and mechanical systems Proficiency in Microsoft Office Suite and ERP systems (e.g., Dynamics/AX) Experience with CRM platforms and facility CMMS systems (e.g., Metasys, Angus) Strong verbal and written communication skills Ability to coach, mentor, and lead teams effectively Understanding of safety protocols and compliance standards Ability to work under pressure in fast-paced and dynamic environments Strong organizational and delegation skills ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $130,000 yearly in our lowest geographic market up to $150,000 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job‑related knowledge, skills, and experience. Applicants must have current work authorization when accepting a position at Syner‑G. Currently, Syner‑G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Manage facility and infrastructure capital projects from scope development through construction, commissioning, qualification, and operational turnover. | Requires a bachelor’s degree in a related technical discipline and 5–7+ years of facilities, project engineering, capital-project, or construction experience, including regulated-manufacturing and GMP knowledge. | COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: Syner-G is seeking a Senior Project Engineer to support capital projects at a large pharmaceutical manufacturing facility utilizing both single-use and stainless-steel processing systems. The Senior Project Engineer will provide owner-side engineering and project execution support for facility, utility, infrastructure, and manufacturing-support projects. Typical projects may include HVAC, cleanrooms, process and plant utilities, cooling towers, electrical systems, laboratory and manufacturing-area modifications, equipment installations, and facility upgrades. The role will coordinate engineering design, procurement, construction, commissioning, and turnover activities while serving as a key interface between site Engineering, Facilities, Manufacturing, Quality, contractors, vendors, and external design partners. KEY RESPONSIBILITIES: Manage multiple facility and infrastructure capital projects from scope development through design, construction, startup, and turnover. Support projects involving HVAC, electrical systems, clean utilities, plant utilities, cooling towers, manufacturing infrastructure, laboratories, and facility modifications. Develop project scope, technical requirements, budgets, schedules, procurement plans, and execution strategies. Serve as the owner-side engineering interface with design firms, contractors, vendors, and internal stakeholders. Review and approve engineering drawings, specifications, shop drawings, submittals, RFIs, equipment packages, and other technical deliverables. Provide technical responses to requests for information and coordinate resolution of field and design issues. Contribute to technical design of facility equipment, utilities, and associated infrastructure. Coordinate process, mechanical, electrical, structural, architectural, HVAC, plumbing, automation, and construction interfaces. Confirm equipment layouts, utility requirements, facility interfaces, and installation requirements. Support equipment and system procurement, vendor evaluations, technical bid reviews, and contractor coordination. Participate in FAT, SAT, commissioning, qualification, startup, and turnover activities as applicable. Coordinate construction activities, shutdown work, tie-ins, equipment installations, and work within active GMP manufacturing areas. Develop and maintain project schedules, cost forecasts, action logs, risk registers, and project status reports. Monitor project costs, commitments, forecasts, change orders, and contractor performance. Support development and implementation of Facility Control Plans and other project-specific execution controls. Collaborate on project-related change controls, deviations, CAPAs, and GMP documentation. Support preventative maintenance, asset turnover, spare-parts planning, and integration with site maintenance systems. Identify technical, schedule, cost, safety, and operational risks and drive mitigation and resolution. Ensure projects consider constructability, maintainability, operability, safety, GMP requirements, and future facility needs. Support development and execution of commissioning and qualification strategies for new and modified facility, utility, and equipment systems. Coordinate FAT, SAT, commissioning, startup, IQ/OQ, and turnover activities with Engineering, Validation, Quality, Facilities, Operations, vendors, and contractors. Review and support development of commissioning plans, qualification protocols, test scripts, turnover packages, and associated technical documentation. Ensure design, installation, commissioning, and qualification activities remain aligned with URS, design requirements, GMP expectations, and project milestones. Track and resolve commissioning punch-list items, discrepancies, deviations, and qualification issues through closure. Support system handoff from construction and engineering into validated and operational use. Coordinate with Validation/CQV teams to ensure projects are designed and executed with qualification requirements considered early in the project lifecycle. Support change control, validation impact assessments, and documentation associated with equipment, utility, and facility modifications. QUALIFICATIONS AND REQUIREMENTS: Education: Bachelor’s degree in Chemical Engineering, or related technical discipline. Technical Experience: 5-7+ years of project engineering, facilities engineering, capital-project, or construction experience. Experience supporting pharmaceutical, biotechnology, medical-device, or other regulated manufacturing environments. Demonstrated experience managing multidisciplinary facility or utility projects. Knowledge, Skills, and Abilities: Ability to interpret engineering drawings, specifications, P&IDs, equipment layouts, electrical one-lines, and construction documents. Experience coordinating engineering firms, contractors, equipment vendors, and internal site stakeholders. Strong project controls experience including schedule, budget, procurement, forecasting, and risk management. Working knowledge of GMP project execution, change control, commissioning, qualification, and turnover. Strong communication, problem-solving, and stakeholder-management skills. Preferred Experience Large-scale pharmaceutical or biologics manufacturing facilities Single-use and stainless-steel manufacturing environments HVAC and cleanroom systems Cooling towers, chilled water, steam, compressed air, and other plant utilities Purified water or clean utility systems Electrical infrastructure Facility shutdowns and tie-ins Construction management Commissioning / CQV / Validation Support Laboratory and manufacturing-area renovations Equipment installation and startup Project cost forecasting RFIs, submittals, shop drawings, and design reviews CMMS / asset-management systems Commissioning and qualification Owner’s-representative or site project-engineering experience ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $120,000 yearly in our lowest geographic market up to $140,000 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job‑related knowledge, skills, and experience. Applicants must have current work authorization when accepting a position at Syner‑G. Currently, Syner‑G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.