Genovice

Compensation

Full Description

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).