CQV Engineer (Commissioning, Qualification, and Validation)

Location: Middletown, DE, US

Employment Type: OTHER

Overview

We are seeking a CQV Engineer (Commissioning, Qualification, and Validation) to join the DP Engineering team at the Middletown drug product facility. The CQV Engineer will support planning, execution, documentation, and closure of commissioning and qualification activities for manufacturing equipment, facilities, utilities, automation interfaces, and supporting systems.

 

This role reports to the CQV Lead / Manager and will work closely with Engineering Management, Manufacturing, Technical Services, Automation/CSV, Quality, EHS, vendors, and external CQV service providers. The position is an individual-contributor role with no direct reports and will help build sustainable internal CQV capability as the site transitions from project start-up into routine GMP operations.

Responsibilities

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.

Qualifications

Required 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.

Preferred Qualifications:

• 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.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.