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1 day ago Be among the first 25 applicants 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

Seniority level Director Employment type

Employment type Contract Job function

Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Invent Staffing by 2x Sign in to set job alerts for “Validation Manager” roles.

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