Senior Engineer - Process Development

Engineer Senior Onsite

In this vital role, the Sr Engineer is responsible for the maintaining off line capbailities 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.

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 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.

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…