MS&T Process Engineer - Pharma

MS&T Process Engineer - Pharma (West Chester, OH)

Our client, a biopharmaceutical contract development and manufacturing organization, is seeking a senior‑level Process Engineer to lead the technical ownership of the visual inspection process for injectable drug products. The role focuses on ensuring that products meet regulatory requirements before reaching patients, as well as leading the technical work required to launch new products and improve existing processes.

The engineer is responsible for the visual inspection of filled containers—vials, syringes, cartridges—ensuring there are no particles, cosmetic defects, cracks, or other safety hazards. This includes validating and maintaining both automated inspection machines and manual inspection procedures, troubleshooting issues, conducting root‑cause analyses, and implementing improvements to keep processes compliant with GMP.

Beyond troubleshooting, the role emphasizes continuous improvement, including increasing inspection line speeds, reducing waste, improving reliability and OEE, and managing capital projects for new equipment. The engineer also acts as the subject‑matter expert during regulatory inspections.

• Own all visual inspection responsibilities for filled container closures including automated and manual processes; define and maintain centerlines, critical process parameters, material fit‑for‑use criteria, and operating procedures.
• Serve as site subject‑matter expert for visual inspection equipment and processes.
• Lead continuous‑improvement initiatives to reduce changeover time, improve yield and OEE, increase maintenance reliability, and reduce waste.
• Define success criteria for technology transfer and process validation; ensure readiness before handoff to manufacturing and generate URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports.
• Perform and maintain risk‑management activities for new and existing processes and equipment.
• Lead process‑validation activities triggered by changes to validated manufacturing processes.
• Participate in annual product reviews and biennial critical systems reviews.
• Initiate deviations and lead technical investigations and impact assessments.
• Identify, develop, and manage change controls to improve processes and resolve root causes.
• Author, review, and approve SOPs, batch records, rework procedures, validation documents, and change requests.
• Coordinate equipment data, capabilities, utilization, and lifecycle management.
• Own user requirements for new asset procurement.
• Develop project justifications, engineering proposals, and support the capital‑planning process.
• Maintain external technical relationships with equipment and material suppliers.
• Identify technical training needs for operations, engineering, and maintenance.
• Provide on‑call support as required.
• Serve as key technical contact during regulatory inspections.

• Significant experience supporting manufacturing operations in a regulated or cGMP environment.
• Demonstrated expertise in visual inspection processes, automated vision systems, and process validation or technology transfer in pharmaceuticals or a comparable GMP environment.
• Experience identifying, justifying, implementing, and testing process improvements in a cGMP environment.
• Track record as a technical subject‑matter expert in visual or process engineering.

• Bachelor’s degree in engineering or a related technical discipline.
• Experience with both automated and manual visual inspection.
• Project‑management experience, including leading equipment installation and qualification efforts.
• Six Sigma or strong analytical troubleshooting skills.
• Experience in a LEAN manufacturing environment.
• Proficiency with quality‑management systems (deviations, change controls, CAPAs).
• Ability to coach and mentor peers.

• Specific visual skills: extensive reading or computer use, normal color vision, depth perception, and visual acuity.
• Specific hearing requirements: interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer…