Validation Engineer – GMP Laboratory

In this vital role, the Sr Engineer is responsible for maintaining offline capabilities space within the Process Development Department which includes validation of laboratory instruments/equipment and be able to provide hands-on training, execution, operation, and sustainment of 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.

Day-to-Day Responsibilities:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. Deviations, CAPAs & Change Controls

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

9. 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.

10. 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.

11. Inspection Readiness

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

12. 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.

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. The 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.