Senior Process Engineer

Position Summary

We have an opportunity for a Senior Process Engineer to join our team supporting the introduction of new biopharmaceutical products at our development and manufacturing sites. This role focuses on liquid formulations produced under single-use systems in a cleanroom environment. The position involves onboarding new process equipment, coordinating commissioning and qualification, and ensuring validated equipment status. It is a full-time, hands-on engineering role within a growing CDMO, offering the chance to make a meaningful impact in a dynamic environment.

The Role

• Provide hands-on support as a bioprocess equipment subject matter expert and manufacturing support engineer.
• Support manufacturing floor operations by troubleshooting bioreactors, fermenters, chromatography skids, centrifuges, fillers, isolators, incubators, and utility systems.
• Collaborate with operators, mechanics, MS&T, and Quality to minimize downtime and resolve equipment issues.
• Execute preventive maintenance programs and close maintenance work orders within the CMMS system.
• Coordinate repairs with vendors and maintenance technicians, managing spare parts and reliability improvements.
• Lead installation of new equipment and support commissioning and qualification activities (IQ/OQ).
• Contribute to facility expansions and technology transfers, working with Validation and Automation teams on SCADA integration.
• Prepare and review GMP documentation including change controls, deviations, CAPAs, SOP revisions, and engineering reports.
• Perform root cause investigations and risk assessments using tools such as FMEA, Fishbone, and 5-Why.
• Train operators, mechanics, and engineers, and support regulatory inspections as the equipment SME.
• Manage contractors and vendors and present engineering updates to leadership and project teams.

Minimum Requirements

• Bachelor’s degree in Engineering required; Chemical or Mechanical Engineering preferred. Equivalent combination of education, certifications, and relevant experience may be considered.
• 5–10 years of engineering or maintenance experience in a GMP-regulated biopharmaceutical or biotechnology manufacturing environment.
• Experience supporting bioprocess equipment, manufacturing operations, and facility systems.
• Experience with aseptic processing and fill/finish operations.
• Experience working within cGMP and regulated pharmaceutical environments.
• Able to navigate site mechanical spaces, including stairs, ladders, and low overhead areas as needed for project support.
• May require occasional work in tight or awkward spaces, such as behind equipment or within cleanroom utility chases.
• Ability to visually inspect equipment, read instruments, and review documentation with clarity and accuracy (corrected vision acceptable).
• Ability to sit at a desk or computer for periods of time to prepare documentation, reports, and data analyses.
• Must be able to lift and carry up to 40 pounds occasionally.
• Manual dexterity sufficient to operate tools, instruments, laptops, and measurement equipment.
• Use of personal protective equipment (PPE) including lab coats, gloves, safety goggles, and, when required, respiratory protection.

Preferred Skills & Background

• Biopharmaceutical manufacturing (strongly preferred).
• CDMO experience (Catalent, Lonza, Thermo Fisher, Fujifilm Diosynth, AGC Biologics, Resilience, WuXi, etc.).
• Sterile injectable or aseptic manufacturing environments.
• Experience in biologics, cell culture, fermentation, and fill/finish operations.
• Experience in medical device, vaccine, or biotechnology manufacturing.
• Experience in adjacent regulated industries with strong process equipment background may be considered.