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- Lead the planning and execution of CQV activities for facilities, utilities, equipment (FUE), and process systems.
- Collaborate with engineering, quality, manufacturing, and IT teams to ensure strategic alignment, including Computer System Validation (CSV) integration.
- Manage deviations, investigations, and change control processes during CQV execution.
- Direct and coordinate efforts of internal teams, vendors, and third-party CQV service providers.
- Review and approve CQV deliverables such as risk assessments, validation master plans, protocols (DQ, IQ, OQ, PQ), and summary reports.
- Represent the site as a member of the global engineering team, supporting global project planning and implementation.
2. Regulatory Compliance
- Ensure all CQV work complies with cGMP, FDA, EMA, ICH, and company-specific quality requirements.
- Lead inspection readiness efforts and represent the CQV function during audits and regulatory inspections.
- Ensure appropriate documentation practices and maintain archival of paper and electronic records (including scan copies, videos, etc.) per regulatory and company guidelines.
3. Project Management
- Manage project timelines, budgets, and resource planning related to CQV deliverables.
- Oversee vendor and contractor performance to ensure adherence to project quality and compliance standards.
- Implement risk-based validation strategies (e.g., ASTM E2500) and drive continuous improvement across CQV practices.
4. Technical Leadership
- Act as Subject Matter Expert (SME) in design and validation for systems such as HVAC, clean utilities (WFI, PW, process gases), aseptic processing equipment, and laboratory instruments.
- Provide technical support for technology transfers, new product introductions, and facility expansions.
- Contribute to investigations (deviations, CAPAs), root cause analysis, and change controls impacting validated systems.
Qualifications
Required:
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical field.
- Minimum 8–10 years of relevant CQV/validation experience in the pharmaceutical or biotechnology industry.
- Minimum 3 years in a leadership or managerial role within CQV or validation.
- Strong understanding of cGMP regulations, risk-based validation (e.g., ASTM E2500), and regulatory expectations (FDA, EMA, ICH).
- Excellent written and verbal communication skills with high attention to detail.
Preferred:
- Experience in facility startup, commissioning, or expansion projects.
- Familiarity with electronic validation/documentation systems (e.g., ValGenesis, Kneat, Veeva Vault).
- Previous experience supporting regulatory inspections and audits.
- Knowledge and experience in isolator-based aseptic filling line validation.
Seniority level
Employment type
Job function
- IndustriesPharmaceutical Manufacturing
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