Commissioning, Qualification, and Validation Lead Engineer

Job Summary:A leading healthcare manufacturing organization is seeking a Commissioning, Qualification, and Validation Lead Engineer to support Oral Solid Dose manufacturing and packaging operations within a regulated GMP environment. This role is responsible for leading commissioning, qualification, and validation activities for manufacturing equipment, utilities, facilities, and computerized systems. The ideal candidate will possess strong engineering fundamentals, hands-on CQV experience, and expertise in validation documentation, compliance, and automation systems.Key Responsibilities:• Lead commissioning, qualification, and validation activities for manufacturing equipment, utilities, facilities, packaging systems, and computerized systems within an Oral Solid Dose environment• Develop and execute risk-based IQ, OQ, and PQ protocols aligned with critical quality attributes and process parameters• Interpret design specifications, functional requirements, and system configurations to create traceable qualification documentation• Support validation lifecycle management activities including change control, deviation investigations, periodic reviews, and requalification assessments• Ensure compliance with current GMP regulations, data integrity standards, and 21 CFR Part 11 requirements• Collaborate with Quality, Manufacturing, Automation, and Engineering teams to ensure inspection readiness and successful project execution• Review system performance data and analyze process reliability to support compliant manufacturing operations• Troubleshoot automation interfaces, control systems, and equipment integration issues impacting qualification activities• Generate and review qualification documentation including protocols, reports, traceability matrices, and validation deliverables• Maintain inspection-ready documentation practices with a strong focus on technical accuracy and regulatory complianceRequired Qualifications:• Master’s degree or Doctorate in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, Automation Engineering, or a related discipline• Minimum 3 years of hands-on CQV experience within a GMP-regulated Oral Solid Dose manufacturing environment• Strong experience developing and executing IQ, OQ, and PQ protocols in regulated industries• Experience with Computerized System Validation, data integrity principles, and 21 CFR Part 11 compliance• Knowledge of Oral Solid Dose manufacturing operations including blending, granulation, compression, coating, and encapsulation processes• Experience working with automation systems including PLC, SCADA, and data historian platforms• Ability to interpret mechanical, electrical, and control system documentation• Excellent technical writing and documentation review skills• Strong analytical, troubleshooting, and risk assessment capabilitiesPreferred Qualifications:• Experience supporting pharmaceutical manufacturing and packaging operations• Familiarity with validation lifecycle management and risk-based validation methodologies• Experience working with digital validation tools and structured documentation systems• Ability to manage cross-functional project activities in fast-paced regulated environmentsBenefits:The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.Pay Range: $45/hr to $50/hr