Senior Validation CQV Engineer

Job Title:

Senior Validation CQV Engineer

Experience:

9+ Years

Industry:

Pharmaceutical / Biotechnology

Position Summary :

We are seeking an experienced Senior Validation CQV Engineer with 9+ years of experience in pharmaceutical or biotechnology environments to support a facility expansion and upgrade project in California. The ideal candidate will have extensive expertise in Commissioning, Qualification, and Validation (CQV) of facilities, utilities, and laboratory/manufacturing equipment within a GMP-regulated environment.

The candidate will lead validation documentation and execution activities, manage periodic reviews, and ensure systems remain in a validated state of control. Strong knowledge of data integrity principles, Quality Management Systems (QMS), and asset management platforms is essential.

Key Responsibilities :

• Develop, review, and maintain validation documentation, including User Requirements Specifications (URS), Design Specifications, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, and final validation reports.
• Execute IQ/OQ/PQ activities for facility infrastructure, clean utilities, and QC/manufacturing equipment.
• Qualify critical pharmaceutical utilities, including HVAC and water systems, along with laboratory and manufacturing instruments such as HPLC systems, bioreactors, and other analytical equipment.
• Lead periodic reviews of validated systems by evaluating asset management records and QMS documentation, including Change Controls, Deviations, and Corrective and Preventive Actions (CAPA).
• Assess system performance, compliance history, and overall system health to recommend requalification or continued operation within the validated state.
• Manage equipment decommissioning, relocation, and requalification activities for existing assets.
• Ensure validation activities comply with GMP requirements, global data integrity standards, and ALCOA+ principles.
• Collaborate with Engineering, Quality Engineering (QE), Quality Assurance (QA), and Operations teams to resolve issues and meet project milestones.
• Maintain accurate, traceable, and audit-ready validation records.
• Identify compliance gaps and recommend corrective actions to maintain a state of control.

Required Qualifications :

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 9+ years of validation/CQV experience within the pharmaceutical, biotechnology, or other GMP-regulated industry.
• Proven experience qualifying pharmaceutical facilities, utilities, and laboratory/manufacturing instrumentation.
• Hands-on experience with HVAC, pharmaceutical water systems, HPLC, bioreactors, and analytical instruments.
• Strong understanding of IQ/OQ/PQ protocols, validation documentation, and qualification lifecycle management.
• In-depth knowledge of data integrity requirements, ALCOA+ principles, and applicable GMP regulations.
• Experience reviewing and managing QMS records, including Change Controls, Deviations, and CAPA.
• Familiarity with asset management systems and their use in periodic reviews and equipment lifecycle management.
• Demonstrated experience with equipment decommissioning, relocation, and requalification.
• Strong analytical skills to evaluate system performance and compliance data and develop technically sound recommendations.
• Excellent technical writing, documentation, communication, and cross-functional collaboration skills.
• Ability to work on-site in California and support project timelines in a fast-paced environment.

Preferred Skills :

• Experience supporting pharmaceutical facility expansions, upgrades, or remediation projects.
• Knowledge of risk-based qualification and periodic review methodologies.
• Experience maintaining validated systems in a state of control.
• Ability to interpret historical validation records, maintenance data, deviations, and change history.

Soft Skills :

• Strong team collaboration and stakeholder management skills.
• Positive, proactive, and solution-oriented mindset.
• Ability to coordinate effectively across Engineering, QA, QE, and Operations.
• Strong attention to detail and commitment to regulatory compliance.
• Ability to manage competing priorities and deliver quality documentation under tight deadlines.