CQV Engineer - Lab Instruments/Pharma/biotech

Description :

This role is a key individual contributor supporting site operations, issue resolution, inspection readiness, and the lifecycle management of validated and compliant laboratory instruments/equipment/systems.

The Sr Engineer provides support to Process Development while partnering closely with Manufacturing, Engineering, Quality, and other cross functional departments.

Key Responsibilities

Validation Leadership & Strategy

• Lead the validations of laboratory systems, equipment, method transfer, and are commissioned, qualified, and maintained in a validated state.
• Develop and execute validation strategies aligned with regulatory expectations, corporate standards, and site business objectives.
• Own or oversee validation governance, including validation plans, lifecycle approaches, and risk-based strategies for PD Laboratory.
• Establish and maintain periodic review and ongoing monitoring programs to ensure continued state of control for validated laboratory systems, equipment, and methods.

Standards, Challenge Kits & Governance

• Establish, implement, and maintain laboratory and validation standards, including standardized approaches for qualification, periodic review, and ongoing verification.
• Oversee the development, qualification, maintenance, and lifecycle management of challenge kits to support equipment qualification, method verification, and manufacturing readiness.
• Ensure challenge kits and test methods are scientifically sound, fit-for-purpose, and consistently applied across PD and manufacturing lines.
• Lead or support analytical and inspection method transfers to the site, ensuring successful deployment, training, qualification, and sustained compliant use.
• Ensure alignment with global and site standards while identifying opportunities to simplify, standardize, and improve compliance outcomes.

PD Laboratory Operations & Execution

• Provide ownership of day-to-day operation, readiness, and compliant use of PD laboratory spaces and equipment, which include device testing equipment, diagnostic tools, and controlled laboratory spaces.
• Serve as primary technical owner for assigned PD laboratory systems and equipment
• Ensure PD laboratory equipment and diagnostic technologies (e.g., X-ray inspection systems, Keyence microscopes, and other forensic analysis tools) are qualified, maintained, and used in alignment with intended use and regulatory requirements.
• Lead and support preliminary assessments of manufacturing component and process issues, partnering with Manufacturing and PD to rapidly identify potential root causes and risk to product quality.
• Partner with PD and Engineering to support new lab build-outs, renovations, modifications, technology introductions, and advanced inspection capabilities.
• Establish and maintain laboratory compliance standards, including expectations for equipment use/inventory, maintenance, documentation, and data integrity.

Compliance, Forensic Investigations & Inspection Readiness

• Ensure laboratory and validation practices align with cGMPs, global regulatory requirements, data integrity expectations, and internal policies.
• Serve as a primary laboratory and validation contact during regulatory inspections, internal audits, and corporate assessments.
• Lead or support forensic investigations related to manufacturing deviations, atypical results, and component or equipment-related failures, including the application of advanced inspection and diagnostic techniques.
• Ensure timely and compliant resolution of deviations, CAPAs, change controls, risk assessments, and laboratory investigations.
• Maintain inspection-ready documentation, systems, and processes at all times.

Business Processes & Operational Excellence (OE)

• Own and continuously improve laboratory and validation business processes, ensuring they are efficient, compliant, and scalable.
• Drive Operational Excellence (OE) initiatives across PD laboratory operations, validation, and compliance activities.
• Apply risk-based, lifecycle, and lean principles to improve execution efficiency while maintaining regulatory compliance.
• Monitor and trend key performance indicators (KPIs) related to validation execution, laboratory compliance health, periodic review status, and inspection readiness.
• Leverage data and metrics to identify trends, risks, and improvement opportunities.

Cross-Functional Collaboration

• Partner with Manufacturing, PD, Engineering, Quality, Facilities & Utilities, and Regulatory to ensure aligned execution of projects and operational priorities.
• Provide validation, laboratory, and diagnostic capability input into capital projects, tech transfers, and process changes.
• Represent Validation and PD Laboratory Operations on site and network governance forums as required.

Basic Qualifications

• Master’s degree and/or 2 years in a GMP-regulated environment
• OR
• Bachelor’s degree and/or 5 years in a GMP-regulated environment

Preferred Qualifications

• Educational background in Engineering, Life Sciences, or a related technical discipline.
• Experience with commissioning, qualification, and validation (CQV) of facilities, utilities, equipment, and laboratory systems.
• Direct Hands-on experience supporting PD laboratories, laboratory equipment, or validation activities.
• Experience with advanced inspection, testing, or forensic diagnostic technologies, supporting manufacturing and development operations.
• Strong knowledge of cGMP regulations, data integrity, laboratory compliance, and validation lifecycle principles.
• Proven experience leading organizations through regulatory inspections.
• Demonstrated ability to influence across functions and organizational levels.
• Strong written and verbal communication skills.
• Experience driving Operational Excellence, business process improvement, and standardization initiatives.
• Ability to thrive in a fast-paced, highly regulated manufacturing and development environment.

Top 3 Must Have Skill Sets:

1. Hands-On Validation & CQV Experience

Demonstrated experience with the end-to-end CQV/validation lifecycle for GMP laboratory instruments/equipment: URS/risk assessment, commissioning, IQ/OQ/PQ or CQ, protocol execution, deviations, change control, validation reports, periodic review, and maintaining equipment in a validated state. Candidate should be an executor, not only a document reviewer.

2. GMP Laboratory Operations & Challenge Kit Experience

Direct, hands-on experience working in a GMP laboratory or manufacturing-support laboratory, including equipment operation, troubleshooting, maintenance/readiness, documentation, data integrity, and inspection readiness. Strong preference for experience developing, qualifying, maintaining, or using challenge kits/reference standards/known defect samples for equipment qualification and verification. Experience with diagnostic/forensic tools such as microscopy, vision systems, X-ray inspection, dimensional inspection, or other advanced inspection technologies is valuable.

3. Dynamic Manufacturing Support & Technical Ownership

Ability to independently own laboratory equipment and capabilities while supporting a fast-paced GMP manufacturing environment. Must be comfortable troubleshooting unexpected issues, supporting deviations/CAPAs/investigations, working cross-functionally with PD, Manufacturing, Engineering, and Quality, and providing hands-on training. Must have the flexibility to work off-shift, extended, or adjusted hours when manufacturing or investigation support requires it.