Lead Computer Systems Validation Engineer I (Clinical & R&D)
Alkermes
August 18, 2026
Remote friendly (Greater Boston)
United States
IT
Responsibilities:
- Support computer system validation (CSV) activities across Quality, Regulatory, and R&D systems, ensuring compliance with regulations, internal policies, and SOPs.
- Represent CSV in project teams; collaborate with stakeholders; measure and report execution progress.
- Apply risk-based validation using tools such as GAMP 5 and Quality Risk Management.
- Develop, review, approve, and execute validation documentation across the system lifecycle.
- Conduct/approve risk assessments per the company Quality Risk Management policy.
- Communicate validation outcomes clearly to reviewers/auditors.
- Apply technical/scientific knowledge to validation approaches and documentation.
- Exposure to validation of AI and AI validation methodology.
- Maintain GxP compliance through monitoring/review/assessment/qualification (Change Control, Deviations, CAPAs, Periodic Reviews, Access Reviews, SOP updates).
- Support compliance with corporate global computerized validation policies and Digital Quality expectations.
- Create/maintain CSV templates in ValGenesis and relevant job aids.
- Support regulatory inspections, internal audits, and third-party/vendor audit activities (including corrective actions to closure).
- Provide training before CSV activities begin; lead/assist validation methodology training content.
- Participate in cross-functional forums and track action items.
- Participate in professional/industry groups.
Qualifications:
- Bachelor’s in computer science, Life Sciences, Engineering, or related field; 9+ years Digital Quality experience in GxP pharma/biotech (or Master’s with 7+ years).
- Preferred: experience supporting CSV in a GxP environment. Required: quality systems, compliance, and data integrity experience, including enterprise quality systems (e.g., LMS, Veeva DMS, TrackWise) and paperless validation platforms (e.g., ValGenesis).
- Knowledge of GxP regulations (e.g., 21 CFR Part 11/312/314, EudraLex Vol 4 & Annex 11, ICH Q7/Q8/Q9/Q10).
- Strong leadership, collaboration, written/verbal communication, and time management; proven results; ability to work cross-functionally; flexibility.
Benefits/Compensation & Work Model:
- Base salary: $110,000–$126,000; annual performance bonus; hybrid work (60% office/40% home), onsite at Waltham, MA at least 3 days/week; not fully remote.
- Support computer system validation (CSV) activities across Quality, Regulatory, and R&D systems, ensuring compliance with regulations, internal policies, and SOPs.
- Represent CSV in project teams; collaborate with stakeholders; measure and report execution progress.
- Apply risk-based validation using tools such as GAMP 5 and Quality Risk Management.
- Develop, review, approve, and execute validation documentation across the system lifecycle.
- Conduct/approve risk assessments per the company Quality Risk Management policy.
- Communicate validation outcomes clearly to reviewers/auditors.
- Apply technical/scientific knowledge to validation approaches and documentation.
- Exposure to validation of AI and AI validation methodology.
- Maintain GxP compliance through monitoring/review/assessment/qualification (Change Control, Deviations, CAPAs, Periodic Reviews, Access Reviews, SOP updates).
- Support compliance with corporate global computerized validation policies and Digital Quality expectations.
- Create/maintain CSV templates in ValGenesis and relevant job aids.
- Support regulatory inspections, internal audits, and third-party/vendor audit activities (including corrective actions to closure).
- Provide training before CSV activities begin; lead/assist validation methodology training content.
- Participate in cross-functional forums and track action items.
- Participate in professional/industry groups.
Qualifications:
- Bachelor’s in computer science, Life Sciences, Engineering, or related field; 9+ years Digital Quality experience in GxP pharma/biotech (or Master’s with 7+ years).
- Preferred: experience supporting CSV in a GxP environment. Required: quality systems, compliance, and data integrity experience, including enterprise quality systems (e.g., LMS, Veeva DMS, TrackWise) and paperless validation platforms (e.g., ValGenesis).
- Knowledge of GxP regulations (e.g., 21 CFR Part 11/312/314, EudraLex Vol 4 & Annex 11, ICH Q7/Q8/Q9/Q10).
- Strong leadership, collaboration, written/verbal communication, and time management; proven results; ability to work cross-functionally; flexibility.
Benefits/Compensation & Work Model:
- Base salary: $110,000–$126,000; annual performance bonus; hybrid work (60% office/40% home), onsite at Waltham, MA at least 3 days/week; not fully remote.