(CQV) Lead Engineer

WuXi AppTec • Middletown, DE

95d

About The Position

We are seeking a highly experienced and detail-oriented CQV (Commissioning, Qualification, and Validation) Lead Engineer to lead the execution of commissioning qualification, and validation activities at our pharmaceutical manufacturing facility. The CQV Lead Engineer is responsible for ensuring all equipment, computerized systems, facilities, and processes meet regulatory and quality standards (FDA, EMA, ICH) and are in a state of control throughout their lifecycle. The ideal candidate will manage cross-functional projects and work teams, interface with contractors and engineering teams, and drive compliant, efficient validation programs across both new and existing operations.

Requirements

• Excellent written and verbal communication skills, with attention to detail and clarity.
• Bachelor's or Master's degree in engineering, Life Sciences, or related technical discipline.
• Minimum of 8-10 years of CQV or validation experience in the pharmaceutical or biotechnology industry.
• Preferably at least 3 years in a supervisory or managerial role.
• Deep understanding of cGMP requirements, risk-based validation principles, and global regulatory expectations.
• Proven experience in startup or expansion of manufacturing facilities is highly preferred.

Nice To Haves

• Strong knowledge of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, ICH), and industry standards.
• Experience with electronic documentation systems (e.g., Valgenesis, Kneat, Veeva Vault) is a plus.
• Prior experience supporting regulatory inspections and audits.
• Experience in design and validation of isolator aseptic filling line.

Responsibilities

• Lead the development and execution of CQV plans for facilities, utilities, equipment (FUE), and process systems.
• Coordinate with engineering, quality, manufacturing teams and IT to ensure alignment on validation strategies includes CSV strategy.
• Coordinate with quality and manage the deviation and change control procedure during CQV phase.
• Manage and lead internal and external resources in executing CQV program, resources include project engineering execution team, vendors and external CQV service providers.
• Develop and approve CQV documentation including risk assessment, protocols (DQ, IQ, OQ, PQ) summary reports, and validation master plans/reports.
• As member of global engineering team, strongly connecting and involving in DP global engineering projects planning and implementation.
• Ensure all CQV activities are executed in compliance with cGMP, FDA, EMA, ICH, and other applicable regulatory guidelines.
• Support inspection readiness and represent CQV function during regulatory inspections and internal/external audits.
• Maintain and archive CQV documentation and file include paper version and E-version (scan copy, video, etc.) in accordance with company standards and regulatory expectations.
• Manage timelines, resources, and budgets for CQV projects.
• Oversee vendor and contractor activities to ensure deliverables are met per pre-established quality requirements.
• Drive continuous improvement and implement risk-based validation approaches (e.g., ASTM E2500).
• Provide subject matter expertise (SME) for design and validation topics including HVAC, clean utilities (e.g., water for injection, purified water, process compressed air, nitrogen, etc.) systems, aseptic processing equipment, and laboratory instruments.
• Support technology transfer, new product introductions, and facility expansions.
• Participate in root cause analysis, change control, and deviation investigations related to validated systems.

What This Job Offers

• Career Level: Senior
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree