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

3 Key Consulting•New Albany, OH

9d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Experience with diagnostic/forensic tools such as microscopy, vision systems, X-ray inspection, dimensional inspection, or other advanced inspection technologies is valuable.
Experience driving Operational Excellence, business process improvement, and standardization initiatives.

Responsibilities

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.
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.
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 or 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.
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.
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.
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.
Ensure the PD Lab is operational, organized, compliant, and ready to support manufacturing.
Verify equipment availability, status, calibration/maintenance, supplies, and general laboratory readiness.
Operate and troubleshoot laboratory and diagnostic equipment such as microscopes, X-ray/inspection systems, device-testing equipment, measurement tools, and other forensic capabilities.
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.
Develop, qualify, maintain, inventory, and periodically verify challenge kits, defect standards, and reference samples used to support equipment qualification and manufacturing readiness.
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.
Serve as technical owner for assigned laboratory equipment—from introduction and qualification through calibration, preventive maintenance, periodic review, change control, upgrades, and eventual retirement.
Create and maintain SOPs, work instructions, protocols, reports, equipment records, logbooks, and other controlled documentation.
Ensure strong GDP and data-integrity practices.
Initiate or support deviations, CAPAs, change controls, risk assessments, and investigation activities associated with laboratory equipment and processes
Provide hands-on training to PD engineers and other users on laboratory equipment, challenge kits, inspection methods, proper documentation, and compliant equipment use.
Work closely with PD, Manufacturing, Quality, Engineering, Validation, Facilities, and vendors on manufacturing support, equipment installations, lab modifications, new technology, and capital projects.
Keep equipment, documentation, validation packages, training records, and laboratory processes continuously inspection-ready and support audits or regulatory inspections when required.
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.