Validation Engineer

Our client is seeking a Validation Contractor to provide quality oversight of the Commissioning, Qualification, and Validation (CQV) program within a regulated pharmaceutical or medical device manufacturing environment. This individual will ensure facilities, equipment, utilities, cleaning procedures, and manufacturing processes remain compliant with applicable cGMP requirements and regulatory standards.

• Minimum of 7 years of experience within the pharmaceutical or medical device industry.
• Minimum of 5 years of hands-on Engineering, Validation, or Commissioning, Qualification, and Validation (CQV) experience.
• Strong working knowledge of 21 CFR Parts 210/211, 600, and 820 (QMSR), ISO 13485, ISO 9001, and ICH Q9/Q10.
• Demonstrated experience reviewing and approving qualification and validation protocols, reports, and supporting documentation.
• Experience supporting deviations, CAPAs, change controls, and regulatory inspection readiness.
• Proficiency with electronic quality management systems such as Documentum, Veeva Vault, and TrackWise.
• Strong analytical, troubleshooting, and problem-solving skills within highly regulated manufacturing environments.
• Excellent communication, organizational, and interpersonal skills with the ability to collaborate across multiple departments and organizational levels.

Education:

• Bachelor's degree in engineering (Biomedical, Chemical, or Mechanical), Biology, Chemistry, Pharmacy, or a related scientific discipline.
• Author, review, and approve User Requirements Specifications (URS), commissioning plans, and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
• Provide risk-based Quality oversight and approval for equipment qualification, Computerized System Validation (CSV), cleaning validation, and process validation activities.
• Review Annual Product Quality Reviews (APQRs) and maintain site Validation Master Plans (VMPs).
• Serve as the Quality Validation subject matter expert for deviations, Corrective and Preventive Actions (CAPAs), and change controls associated with qualification, validation, facilities, and utilities.
• Collaborate with MSAT, Validation, Engineering, Manufacturing, Metrology/Maintenance, and QC teams during Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and facility start-up activities.
• Support internal and external audits, client audits, and regulatory inspections as a Validation Quality SME.
• Monitor and evaluate executed validation packages, track and trend program performance, identify compliance risks, and report key performance indicators (KPIs) to leadership.
• Review quality records, Standard Operating Procedures (SOPs), and manufacturing support documentation to ensure accuracy, completeness, proper record retention, and cGMP compliance.
• Identify opportunities for continuous improvement within the CQV program and support the implementation of quality initiatives.
• Provide guidance, training, and compliance support to junior QA Validation specialists and cross-functional teams.