Senior Process Engineer

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.

Shift: Monday-Friday 8am-5pm

Location: Harmans, MD - BWI

100% Onsite

• ◆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.

The Candidate

• ✓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.