CQV Engineer (Commissioning, Qualification, and Validation)

WuXi AppTec • Middletown, DE

4d

About The Position

The CQV Engineer (Commissioning, Qualification, and Validation) joins the DP Engineering team at the Middletown drug product facility. The role supports planning, execution, documentation, and closure of commissioning and qualification activities for manufacturing equipment, facilities, utilities, automation interfaces, and supporting systems. It reports to the CQV Lead / Manager and collaborates with Engineering Management, Manufacturing, Technical Services, Automation/CSV, Quality, EHS, vendors, and external CQV service providers. This is an individual-contributor position with no direct reports, helping build sustainable internal CQV capability as the site transitions from project start-up to routine GMP operations.

The Engineer applies risk-based CQV approaches and site procedures to qualify systems for GMP use, maintain inspection-ready records, resolve actions and discrepancies, coordinate execution and turnover, and support quality and continuous-improvement activities. The position may also support requalification, periodic review, and lifecycle qualification of existing or modified systems.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• At least 3 years of commissioning, qualification, validation, engineering, or pharmaceutical manufacturing experience.
• Working knowledge of cGMP qualification principles and lifecycle documentation for pharmaceutical facilities, utilities, manufacturing equipment, and/or automated systems.
• Hands-on experience authoring or executing qualification protocols such as DQ, IQ, OQ, and PQ, and documenting discrepancies, deviations, and corrective actions.
• Ability to review technical drawings, equipment documentation, specifications, P&IDs, instrument lists, and vendor test packages.
• Strong organizational and documentation skills, including the ability to manage multiple systems, priorities, and field activities in a fast-paced project/start-up environment.
• Effective communication and collaboration skills across Engineering, Manufacturing, Quality, Automation/CSV, vendors, and contractors.

Nice To Haves

• Experience in oral solid dosage and/or sterile drug product manufacturing environments.
• Experience with equipment FAT/SAT, commissioning turnover, risk-based verification, ASTM E2500 principles, or similar science- and risk-based CQV approaches.
• Experience with electronic quality/document systems such as Veeva or similar platforms.
• Familiarity with 21 CFR Parts 210/211, data integrity expectations, GAMP 5 concepts, and validation of computerized or automated manufacturing equipment.
• Experience supporting greenfield facility start-up, major capital expansion, technology transfer, or rapid operational readiness programs.

Responsibilities

• Support development and execution of risk-based commissioning and qualification strategies, plans, and schedules for facilities, utilities, equipment, and supporting systems.
• Author, review, execute, and close CQV documentation, including risk assessments, DQ, IQ, OQ, and PQ protocols, test scripts, turnover packages, traceability documentation, and summary reports.
• Coordinate field execution with Engineering, equipment vendors, contractors, Automation/CSV, Manufacturing, and Quality, ensuring prerequisites, documentation, and test readiness.
• Review vendor documentation and use FAT, SAT, commissioning, and vendor test records where appropriate while maintaining GMP compliance.
• Track punch-list items, open actions, deviations, and protocol exceptions through resolution and documented closure.
• Perform CQV work in accordance with site procedures, approved protocols, cGMP requirements, and applicable regulatory expectations.
• Support deviations, investigations, change controls, CAPA, and quality risk assessments related to commissioning and qualification.
• Ensure systems are documented and transferred into a controlled and qualified state before GMP use.
• Maintain inspection-ready qualification files and support internal audits, customer audits, and regulatory inspections as required.
• Partner with Equipment Engineering and Technical Services to verify design intent, installation, utilities, safety features, instruments, alarms, interlocks, and operating ranges during qualification.
• Coordinate with Automation/CSV to assess and test computerized and automated functions and link them to the overall equipment qualification strategy.
• Support qualification of drug product manufacturing and packaging equipment and, as assigned, facility and utility systems that directly support drug product operations.
• Assist with requalification, periodic review, and lifecycle qualification for modified or existing systems.
• Maintain CQV status, schedule, document metrics, and completion forecasts for assigned systems, and communicate risks and recovery actions to the CQV Lead / Manager.
• Support contractor oversight and review external CQV deliverables for technical quality, completeness, and alignment with site standards.
• Contribute to developing and improving site CQV templates, procedures, execution practices, and lessons learned.
• Coordinate turnover of qualified systems to Manufacturing and Technical Services with complete documentation and clearly assigned lifecycle actions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level