CQV Engineer: GMP Start-Up & Qualification Expert

Wuxi Apptec, Inc.; Town of Middletown (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Wuxi Apptec, Inc. in Middletown, NY, is seeking a CQV Engineer to support commissioning, qualification, and validation for manufacturing equipment, facilities, utilities, and automation interfaces.

The role involves planning, executing, documenting, and closing CQV activities in a GMP environment. The position reports to the CQV Lead/Manager and collaborates with Engineering, Manufacturing, Quality, Automation/CSV, and external service providers to build internal CQV capability as the site

Qualifications

• 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.

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, 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.
• 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.
• 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.
• 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.

Skills

cGMP principles

Documentation skills

Communication skills

Review technical drawings

Multitasking

Education

Bachelor's degree in Engineering or related field

Tools

Veeva or similar QMS

Job description

Wuxi Apptec, Inc. in Middletown, NY, is seeking a CQV Engineer to support commissioning, qualification, and validation for manufacturing equipment, facilities, utilities, and automation interfaces.

The role involves planning, executing, documenting, and closing CQV activities in a GMP environment. The position reports to the CQV Lead/Manager and collaborates with Engineering, Manufacturing, Quality, Automation/CSV, and external service providers to build internal CQV capability as the site