Genovice

Lead and deliver professional services engagements, including solution design, business analysis, configuration, customization, testing, and deployment. Collaborate with clients to understand their business needs and translate them into effective solutions. | Candidates should have MasterControl experience and a strong understanding of software solutions and implementation principles. A BS in a related technical degree is preferred, along with 3+ years of work experience. | This is a remote position. Job title: Software Implementation Consultant Job Type: 6 Months with possibility of converting to permanent- Hours: Part time Location: 100% Remote Genovice is looking for a contractor to fulfill its needs providing consulting services in the regulated life sciences sector, part (20-25hours weekly). Job Responsibilities Lead and deliver professional services engagements, including solution design, business analysis, configuration, customization, testing, and deployment. Collaborate with clients to understand their business needs, requirements, and objectives, and translate them into effective solutions. Collaborate with cross-functional teams and stakeholders to identify project requirements, set priorities, and manage project scope. Develop and maintain project documentation, including requirements, design specifications, and technical reports. Able to configure, use, demonstrate, and implement quality management solutions in regulated industries. Identify solutions to solve customer issues. Ability to manage multiple projects at any time. Minimum Requirements/Qualifications MasterControl Experience Required Eager to learn and able to execute in a fast-paced environment BS in Computer Science, Management Information Systems or related technical degree preferred 1. Equivalent work experience acceptable 3+ years work experience Demonstrate self-discipline and motivation in all aspects of job performance Strong understanding of software solutions, implementation principles, and industry best practices. Excellent problem-solving, communication, and client relationship management skills. Strong troubleshooting skills Ability to communicate technical concepts to technical and non-technical audience Able to complete assignment with minimal direction Must be able to work in a team environment, handle multiple tasks and react quickly to problems and issues Strong skills in server-based software Non-Negotiable Hiring Criteria Strong attention to detail Strong oral and written communication skills

Manage and coordinate validation project deliverables and timelines, author and review validation documentation, maintain traceability matrices, and ensure compliance with FDA/EMA regulations. | Bachelor's degree in relevant field, minimum 5 years of CSV or CSA project experience in pharma/biotech/medical device industries, 5 years project management experience, familiarity with validation deliverables and regulatory standards. | This is a remote position. Job Description – Part-Time Validation Project Manager / Specialist Position: Part-Time CSV Validation Project Manager / Validation Specialist Location: Remote Commitment: ~10–15 hours per week (Sept–Dec 2025, with possibility of extension) Role Overview Our client is executing a comprehensive validation project to support compliance with FDA and EMA regulations for its IoT-enabled life sciences technology. We are seeking a part-time Validation Project Manager / Specialist to assist with planning, authoring, coordination, and review of validation deliverables. This role will act as project manager and provide support to the lead validation consultant. Key Responsibilities Assist in drafting and reviewing validation deliverables (URS, VMP, RA, IQ/OQ protocols, SOPs). Support coordination of project timelines, resource tasks, and review cycles. Drive meeting to report timeline and deliverables to stack holders Track action items and facilitate communication between validation lead, stack holders, and testing teams. Help maintain the Validation Traceability Matrix (TM) to ensure alignment between URS, RA, and protocols. Provide secondary review of test evidence (screenshots, logs, execution records). Assist with SOP development. Ensure documentation meets regulatory standards (21 CFR Part 11, GxP, Annex 11). Support preparation of the Final Validation Report (FVR). Qualifications Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field. Min 5 years’ experience in Computer System Validation (CSV) or Computer Software Assurance (CSA) projects in pharma/biotech/medical device industries. Must made min 5 yeas Project Manager experience Familiarity with validation lifecycle deliverables (URS, RA, IQ, OQ, VMP). Knowledge of GMP, Part 11, Data Integrity, and Annex 11 requirements. Strong organizational and project coordination skills. Ability to work part-time and independently with minimal supervision. Preferred Skills Prior experience supporting start-up or fast-paced environments. Hands-on authoring of validation SOPs. Familiarity with IoT or lab automation systems is a plus. Engagement Terms Contractor Part Time role Estimated 10–15 hrs/week (Sept–Dec 2025), with possible extension. Compensation: (Depends on experience).