Computer Systems Validation (Analytical Equipment), Specialist IV
About The Position
The Analytical Equipment Validation (AEV) Specialist, Level 4 provides team leadership and training to assess new and changing analytical computer systems to ensure compliance with company policies, procedures and industry guidance. Assess risk and implement a risk based approach to categorize computerized systems, change requests from a Validation standpoint and support completion of validation activities for new and existing systems. The AEV Specialist role will support end to end validation lifecycle, from initiation to decommissioning of analytical systems, and collaborate with both internal and external customers. Be involved as the Analytical Computer System Subject Matter Expert (SME), during small and large-scale projects.
Requirements
- Bachelor’s degree in computer science, engineering, or related field.
- At least 5+ years of experience in computer systems validation.
- 5+ years of Experience in working in a cGMP facility.
- Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation. ( especially for analytical computerized systems).
- Works independently and in teams.
- Background in biotech, pharma, or medical device industry.
- Ability to work independently and on-site in Portsmouth NH.
Responsibilities
- Lead end-to-end validation for analytical equipment as a Subject Matter Expert (SME), ensuring strict adherence to cGMP and quality standards.
- Manage Computer System Validation (CSV) and Data Integrity (DI) assessments for all system changes and existing computerized platforms.
- Execute validation maintenance through periodic reviews and the authorship of Validation Plans, Reports, and Master Plans.
- Review and approve technical protocols, including IQ/OQ/PQ and TrackWise quality records, to ensure compliance.
- Conduct specialized risk assessments, including ERES, Data Integrity Risk Assessments (DIRA), and Audit Trail Risk Assessments (ATRA).
- Drive gap remediation by identifying process deficiencies and managing Deviations and Corrective and Preventive Actions (CAPA).
- Provide cross-functional leadership by mentoring junior specialists and collaborating with teams to ensure on-time closure of quality records.
Benefits
- A collaborative and inclusive work environment.
- Opportunities for career growth and development.
- Access to cutting-edge technologies and tools.
- Competitive compensation and benefits package.
- 401(k) matching plan.
- Supportive leadership and mentoring.
- Commitment to ethical and sustainable practices.
- Relocation assistance is available for eligible candidates and their families.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
