Process Engineer

JOB Description:

Seeking a senior process/facility engineer to support a preliminary facility-fit study within a regulated biopharmaceutical manufacturing environment. The consultant will evaluate planned process equipment against an existing GMP manufacturing suite and determine whether the equipment, process requirements, facility layout, and available utilities can be successfully integrated. Responsibilities will include reviewing equipment specifications, developing implementation layouts, evaluating personnel and material flow, identifying facility and utility gaps, recommending facility modifications, supporting preliminary URS development, and developing preliminary cost and schedule estimates. The engineer will work closely with Process, Manufacturing, MSAT, Facilities, Validation, and other technical SMEs and should be comfortable independently driving technical discussions and documenting recommendations.

Qualifications:

• Biopharmaceutical Engineering: Strong engineering experience within pharmaceutical, biologics, cell and gene therapy, or comparable GMP manufacturing environments.
• Process Equipment Integration: Demonstrated experience evaluating manufacturing equipment requirements against existing facility capabilities.
• Facility Fit / Gap Assessments: Experience performing facility-fit studies, equipment-to-facility gap assessments, or similar front-end engineering activities.
• Process Layout: Experience developing or reviewing GMP process layouts, equipment placement, accessibility, ergonomics, and personnel/material flow.
• USP / DSP: Experience supporting upstream and/or downstream bioprocess manufacturing environments strongly preferred.
• Utilities: Working knowledge of the utility requirements associated with biopharmaceutical process equipment.
• URS Development: Experience developing technical requirements or User Requirement Specifications for facility or equipment modifications.
• CQV Awareness: Understanding of commissioning, qualification, and validation requirements associated with equipment and facility changes.
• Cost / Schedule: Ability to contribute to preliminary project cost estimates, implementation schedules, and execution planning.
• Cross-Functional Leadership: Ability to independently engage Manufacturing, MSAT, Facilities, Quality, Validation, and Engineering SMEs to obtain information and drive decisions.

Ideal Candidate Profile:

A senior-level biopharmaceutical process or facility engineer who has previously taken an equipment list or new manufacturing process, evaluated whether it can operate within an existing GMP suite, identified the technical gaps, and developed a practical implementation plan. The strongest candidate will combine process engineering knowledge with facility-layout and utility awareness and will be comfortable independently leading technical discussions.