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Senior CQV Operations Specialist
2 weeks ago
Job Title: Senior CQV Trainer
Job Summary:
We are seeking an experienced Senior Commissioning, Qualification and Validation (CQV) professional to support our global projects remotely. The ideal candidate will have a deep understanding of regulatory requirements including FDA, EU and ISO standards.
The successful candidate will be responsible for leading and executing CQV activities for manufacturing equipment, utilities and computerized systems in compliance with industry standards. They will also develop and review CQV documentation, manage validation master plans and collaborate with cross-functional teams to ensure seamless integration into capital and remediation projects.
Key Responsibilities:
- Lead and execute CQV activities for manufacturing equipment, utilities (e.g. HVAC, WFI, clean steam), and computerized systems in compliance with regulatory and industry standards.
- Develop and review CQV documentation including User Requirements Specification, Design Qualification, Factory Acceptance Test, Site Acceptance Test, Installation Qualification, Operational Qualification, Performance Qualification and risk assessments (e.g. Failure Mode and Effects Analysis).
- Manage and implement validation master plans (VMP) and system impact assessments.
- Collaborate with cross-functional teams (engineering, quality assurance, manufacturing, IT) to ensure seamless CQV integration into capital and remediation projects.
- Conduct remote FAT/SAT support, data review, and validation strategy planning.
- Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
- Ensure documentation complies with GAMP 5, FDA, EMA and ISO 13485 requirements.
- Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
- Drive continuous improvement and risk-based validation strategies in line with current industry best practices.
Required Skills and Qualifications:
- Bachelor's or Master's degree in Engineering, Life Sciences or a related field.
- 10+ years of hands-on CQV experience in the pharmaceutical and medical device industries.
- Deep understanding of regulatory requirements including FDA, EU Annex 15, ICH Q8-10 and ISO 13485.
- Expertise in GAMP 5, 21 CFR Part 11 and risk-based validation.
- Experience working in remote project environments.
- Proficient in using validation lifecycle software and document management systems.
- Excellent communication and technical writing skills.
Preferred Qualifications:
- Experience with sterile manufacturing, biologics, cell/gene therapy or combination products.
- CQV experience in greenfield or brownfield capital projects.
- Knowledge of Agile, Lean Six Sigma or project management certifications (e.g. PMP).
- Prior experience working with global, cross-cultural teams remotely.
Tools & Platforms:
- Veeva Vault, ValGenesis, TrackWise, Kneat Gx
- Microsoft Office Suite, MS Project, SharePoint
- Remote collaboration tools (MS Teams, Zoom, Slack)
