Slipstream IT

Provide end user service desk support via phone, email, and chat, managing tickets and resolving hardware and software issues remotely. | Requires CompTIA A+ certification, 2-3 years technical support experience, proficiency with Microsoft 365, Windows 10, Active Directory, Mac OS, and ticketing systems like ServiceNow. | Introduction At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations. Slipstream’s industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth. Available Shift Monday-Friday 8:00am-5:00pm EST Monday-Friday 11:00am-8:00pm EST Responsibilities • Provide white-glove, End User Service Desk Support via phone, email, and chat. • Manage incidents and requests within the ServiceNow, Freshservice or Zendesk ticketing systems. • Perform and document daily ticket follow-ups with end users within respective ticketing system • Resolve username and password problems. • Perform uninstall/reinstall of approved software applications to devices. • Provide Multifactor Authentication, Single Sign-On and VPN Support. • Perform software and application support. • Provide remote hardware support for laptops, tablets, mobile devices, monitors, docking stations, printers and accessories. • Provides support for general “how-to” inquiries. Required Skills • CompTIA A+ certification. • Experience supporting Microsoft 365, Windows 10, and Active Directory. • 1+ year Mac OS experience. • Experience with the ServiceNow ticketing system. • Experience with Freshservice and/or Zendesk ticketing systems a plus. • Experience with remote access tools such as LogMeIn, TeamViewer, and Take Control. • Experience Remotely troubleshooting windows hardware and software break/fix issues. • 2-3 years of progressive experience in a Technical Support role with and MSP or call center IT support environment. • Technical proficiency with common hardware, software, and technologies: Windows, Office, iOS, laptops, tablets, Mobile Device Management (MDM), VPN, & WiFi). • Knowledge of Active Directory, Azure, O365, MFA, SSO, networking and server concepts. • Understanding of call center metrics and KPIs. • College or technology school degree preferred. • Ability to multi-task and experience working in a fast-paced environment. • Strong technical troubleshooting and customer service skills. • Strong verbal and written communication skills. Benefits • 401k match • Comprehensive group health, dental, vision benefits • Life insurance/LTD • Discretionary PTO • Salary: $40,000-$42,000 Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time. This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.

Lead and improve the global CSV program ensuring regulatory compliance, manage validation deliverables, lead audits, and build a high-performing validation team. | Bachelor’s or Master’s in CS, Engineering or Life Sciences, 10+ years progressive CSV experience in GxP-regulated environments, expertise in regulatory standards, and leadership skills. | Introduction At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations. Slipstream’s industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth. Job Summary The Director, Software Validation, is responsible for establishing, maintaining, and continuously improving the company’s Computer System Validation (CSV) program in alignment with applicable regulatory requirements, corporate quality policies, and industry best practices. This includes oversight of validation activities for all GxP-related computerized systems used in manufacturing, laboratory, clinical, and quality operations. Regulatory & Standards Scope This position ensures compliance with: GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. 21 CFR Part 11: Electronic Records; Electronic Signatures. EudraLex Volume 4 Annex 11: Computerized Systems. FDA Guidance on Data Integrity and Compliance With CGMP. FDA Draft Guidance on Computer Software Assurance (CSA). Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). ICH E6 (R2) Good Clinical Practice Guideline. Key Duties & Responsibilities • Strategic Leadership Develop and implement a global CSV and CSA strategy. • Ensure alignment of CSV activities with company and regulatory requirements. • Lead organizational readiness for evolving regulatory expectations. • Operational Management Create validation deliverables including plans, risk assessments, protocols, and reports. • Ensure robust change control, periodic review, and system decommissioning processes. • Promote adoption of risk-based validation methodologies. • Compliance & Audit Readiness Serve as primary SME for CSV and data integrity during audits and inspections. • Lead remediation of any validation-related findings. • Maintain documentation and metrics to demonstrate compliance. • Cross-Functional Collaboration Partner with Quality, R&D, and Clinical Operations in execution of CSV activities. • Provide CSV training and mentoring to internal teams. • Team Development Build, develop, and lead a high-performing validation team. • Ensure adequate resourcing for current and future validation projects. Education & Experience Requirements • Bachelor’s or Master’s in Computer Science, Engineering, or Life Sciences. • Minimum 10 years of progressive CSV experience in a GxP-regulated environment. • Demonstrated expertise with GAMP 5, 21 CFR Part 11, Annex 11, FDA Data Integrity guidance, and CSA. • Strong working knowledge of GMP, GCP, GLP, and ICH E6. • Experience managing cross-functional global validation programs. Competencies & Skills • Deep understanding of software development lifecycles and validation approaches. • Exceptional leadership and team-building skills. • Strong analytical, problem-solving, and decision-making abilities. • Excellent written, verbal, and presentation skills. • Ability to thrive in a fast-paced, regulated environment. Work Environment & Travel • Primarily office-based or remote with periodic on-site presence as required. • Occasional domestic/international travel for audits, vendor assessments, or project support. Hourly Rate • $65/hour. Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time. This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.