CQV Engineer: GMP Commissioning & Validation Specialist

WuXi AppTec Group; Town of Middletown (NY); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

WuXi AppTec Group in Middletown, NY is seeking a CQV Engineer to support planning, execution, documentation and closure of commissioning and qualification activities for manufacturing equipment, facilities, utilities, automation interfaces, and supporting systems.

You will work with CQV Lead/Manager and cross-functional teams to build internal CQV capability as the site transitions from project start-up to routine GMP operations, ensuring cGMP compliance and thorough documentation.

Formación

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline with 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 with 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.

Responsabilidades

• CQV Planning and Execution
• 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, PQ protocols, test scripts, turnover packages, traceability documentation, and summary reports.
• Coordinate field execution with Engineering, equipment vendors, contractors, Automation/CSV, Manufacturing, and Quality to ensure prerequisites, documentation, and test readiness are in place.
• Review vendor documentation and leverage FAT, SAT, commissioning, and vendor test records where appropriate to support efficient qualification while maintaining GMP compliance.
• Track CQV punch-list items, open actions, deviations, and protocol exceptions through timely resolution and documented closure.
• GMP and Quality Compliance
• Execute 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 associated with commissioning and qualification activities.
• Ensure systems are appropriately 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.
• Equipment / Automation / Facility Interface
• Partner with Equipment Engineering and Technical Services to verify equipment design intent, installation, utilities, safety features, instruments, alarms, interlocks, and operating ranges during qualification.
• Coordinate with Automation/CSV to ensure computerized and automated functions are appropriately assessed, tested, and linked 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 activities for modified or existing systems.
• Project Controls and Continuous Improvement
• Maintain accurate 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 development and improvement of 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.

Conocimientos

CQV experience

cGMP knowledge

Documentation skills

Cross-functional collaboration

Vendor management

Educación

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline

Herramientas

Veeva

Descripción del empleo

WuXi AppTec Group in Middletown, NY is seeking a CQV Engineer to support planning, execution, documentation and closure of commissioning and qualification activities for manufacturing equipment, facilities, utilities, automation interfaces, and supporting systems.

You will work with CQV Lead/Manager and cross-functional teams to build internal CQV capability as the site transitions from project start-up to routine GMP operations, ensuring cGMP compliance and thorough documentation.