Senior Validation Engineer CQV, GMP LAB Equipment - (JP15912)

Job Title: Senior Validation Engineer CQV, GMP LAB Equipment - (JP15912)

Location: New Albany, OH. 43054

Employment Type: Contract

Business Unit: Site Process Development

Duration: 12 months with likely extensions and/or conversion to permanent

Posting Date: 09/25/2026

Pay Rate: $40 - $45/hour W2 with benefits

Notes: Onsite New Albany, OH- day shift

3 Key Consulting is hiring a Senior Validation Engineer – GMP Manufacturing for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

In this vital role, the Sr Engineer is responsible for the maintaining off line capabilities space within Process Development Department which includes validation of laboratory instruments/equipment and be able to provide hands-on training, execution, operation, and sustainment laboratory operations. This role has specific accountability for the general PD laboratory spaces, challenge parts/kits, and preliminary diagnostic capabilities that support manufacturing and development activities.

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.

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.

Why is the Position Open?

Supplement additional workload on team

Top Must Have Skills:

• 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.

• 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.

• 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.

Day to Day Responsibilities:

• PD Laboratory Operations & Readiness

Ensure the PD Lab is operational, organized, compliant, and ready to support manufacturing. Verify equipment availability, status, calibration/maintenance, supplies, and general laboratory readiness.

• Hands-On Laboratory Equipment Support

Operate and troubleshoot laboratory and diagnostic equipment such as microscopes, X-ray/inspection systems, device-testing equipment, measurement tools, and other forensic capabilities.

• Validation & CQV Execution

Develop, review, and execute qualification/validation protocols for new or modified laboratory equipment. Support commissioning, IQ/OQ/PQ/CQ, deviations, reports, and equipment release for use.

• Challenge Kit Management

Develop, qualify, maintain, inventory, and periodically verify challenge kits, defect standards, and reference samples used to support equipment qualification and manufacturing readiness.

• Manufacturing Issue / Investigation Support

Respond to manufacturing issues requiring laboratory analysis. Perform preliminary diagnostic/forensic assessments of components, packaging, devices, or equipment-related failures and provide technically sound results to investigation teams.

• Equipment Lifecycle Ownership

Serve as technical owner for assigned laboratory equipment - from introduction and qualification through calibration, preventive maintenance, periodic review, change control, upgrades, and eventual retirement.

• GMP Documentation & Compliance

Create and maintain SOPs, work instructions, protocols, reports, equipment records, logbooks, and other controlled documentation. Ensure strong GDP and data-integrity practices.

• Deviations, CAPAs & Change Controls

Initiate or support deviations, CAPAs, change controls, risk assessments, and investigation activities associated with laboratory equipment and processes

• Training & Capability Building

Provide hands-on training to PD engineers and other users on laboratory equipment, challenge kits, inspection methods, proper documentation, and compliant equipment use.

• Cross-Functional & Project Support

Work closely with PD, Manufacturing, Quality, Engineering, Validation, Facilities, and vendors on manufacturing support, equipment installations, lab modifications, new technology, and capital projects.

• Inspection Readiness

Keep equipment, documentation, validation packages, training records, and laboratory processes continuously inspection-ready and support audits or regulatory inspections when required.

• Operational Excellence & Flexibility

Track laboratory KPIs, identify process improvements, standardize laboratory practices, and support manufacturing priorities. Be willing to flex hours/off-shift support when equipment issues, investigations, qualification activities, or production schedules require it.

Basic Qualifications:

Masters degree and 2 years of experience OR Bachelors degree and 5 years of experience

Employee Value Proposition:

Unique industry opportunity

Red Flags:

• Validation experience is documentation-only

Candidate has reviewed/approved protocols but cannot explain equipment they personally qualified, tests they executed, deviations they encountered, or how they established equipment readiness.

• Limited hands-on laboratory experience

Strong GMP background but little experience actually operating, troubleshooting, maintaining, or qualifying laboratory instruments/equipment.

• No challenge kit / defect standard experience

Cannot explain challenge units, known-defect standards, reference samples, positive/negative controls, or how these are qualified, controlled, stored, tracked, and periodically verified.

• Cannot explain end-to-end CQV

Struggles to walk through URS → risk assessment → design/specification → FAT/SAT → IQ/OQ/PQ/CQ → release → periodic review/lifecycle management and their personal role in each stage.

• Weak troubleshooting / investigation skills

Immediately changes settings or assumes root cause rather than observing the failure, gathering data, reproducing the issue, isolating variables, testing hypotheses, and documenting conclusions.

• Needs significant direction

Candidate is accustomed to receiving clearly defined assignments rather than independently owning equipment, prioritizing competing requests, coordinating vendors, and driving issues to closure.

• Cannot train others hands-on

Can execute work themselves but struggles to explain equipment operation, demonstrate procedures, develop training, or qualify other users.

• Weak cross-functional communication
• Has difficulty describing how they have worked with Manufacturing, Quality, Engineering, Validation, vendors, and technical SMEs to resolve an issue.
• Unable or unwilling to occasionally support off-shift, weekend, shutdown, qualification, or manufacturing activities when required.

Interview process:

Virtual Interviews with Hiring Manager

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.