MS&T Process Engineer - Pharma

Position: MS&T Process Engineer  - Pharma
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…