MS&T Process Engineer- Pharma (West Chester, OH)
Our client, a  biopharmaceutical CDMO, is currently hiring a Process Engineer for their injectable drug product team.  This is a senior-level manufacturing/process engineering role focused on making sure pharmaceutical products are inspected accurately, efficiently, and compliantly before they reach patients, while also leading the technical work required to launch new products and improve existing processes.

This role is essentially the technical owner of the visual inspection process for injectable drug products. Once a drug is filled into a vial, syringe, or cartridge, it must be inspected to make sure there are no particles, cosmetic defects, cracks, or other issues that could impact patient safety. This person is responsible for making sure both the automated inspection machines and any manual inspection processes work consistently, efficiently, and meet regulatory requirements.

A large part of the job involves helping bring new products into the facility. When a new drug is transferred to the site for manufacturing, this engineer evaluates whether the inspection process will work, helps validate the equipment and process, runs studies, documents results, and ensures everything is proven to work before Manufacturing takes ownership.

The Process Engineer will also act as the site’s subject matter expert for visual inspection. If inspection equipment has problems, yields drop, defects increase, or regulators ask questions during an audit, this is the person everyone turns to for answers. They will investigate issues, determine root causes, implement improvements, and ensure processes remain compliant with GMP requirements.

Beyond troubleshooting, the role focuses heavily on continuous improvement. The engineer looks for ways to make inspection lines run faster, reduce waste, improve reliability, minimize downtime, and increase productivity. They also help select and qualify new equipment, support capital projects, write procedures and validation documents, and train operations teams on best practices.

The MSAT / MS&T Process Engineer IV has responsibility for execution of technical aspects of product and/or process technology transfer to the site through successful completion of PPQ. This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete, validated process to manufacturing. Individuals in this role work closely with Validation, PMO, Supply Chain, Operations, Quality, and technical experts performing transfers to the site to ensure process implementation to commercial manufacturing follows project timelines and corporate standards.

Key Responsibilities:
Visual Inspection- Own all MSAT responsibilities related to visual inspection of filled container closures (automated and manual).Define and maintain visual inspection centerlines, critical process parameters, material fit-for-use criteria, and operating procedures to ensure process capability.
Serve as site SME for visual inspection equipment and processes.
Lead continuous improvement efforts including changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated inspection equipment.
Technology Transfer & Validation- Define success criteria for technology transfer and process validation; ensure processes are capable prior to handoff to Manufacturing
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 required as a result of changes to validated manufacturing processes.
Participate in annual product reviews and biennial critical systems reviews
Change Control & Investigations- Initiate deviations and lead or facilitate technical investigations and impact assessments.
Identify, develop, and manage change controls to improve processes and address root causes.
Author, review, and approve SOPs, batch records, rework procedures, validation documents, and change requests.
Asset & Project Management – Coordinate equipment data, capabilities, utilization, efficiencies, and lifecycle management.
Own user requirements for new asset procurement.
Develop project justifications and engineering proposals, including input to the capital planning process.
Maintain external technical relationships with equipment and material suppliers.
Operations Support -Identify technical training needs for Operations, Engineering, and Maintenance.
Provide on-call support as required.
Serve as key technical contact during regulatory inspections.

Minimum Qualifications:
Significant experience supporting manufacturing operations in a regulated or cGMP environment.
Demonstrated experience 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.
Established track record as a technical SME in visual or process engineering.

Preferred Qualifications:
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 analytical troubleshooting skills.
Experience in a LEAN manufacturing environment.
Proficiency with quality management systems (deviations, change controls, CAPAs).
Ability to coach and mentor peers.

This position may also include the following conditions: Specific visual skills (i.e., extensive reading or computer use, normal color vision, depth perception, or 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 screen, monitor, reports and other documents.

Client is a biopharmaceutical CDMO (Contract Development and Manufacturing Organization). They help biotech and pharmaceutical companies develop, manufacture, and scale complex medicines when those companies either do not have their own manufacturing capabilities or need additional capacity. 
Think of them as the manufacturing partner behind the scenes for drug companies. A biotech company may discover a promising therapy, but making that therapy at commercial scale requires specialized facilities, equipment, quality systems, and regulatory expertise- working here, you’re taking that product from development through clinical trials and into commercial manufacturing.

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