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.

Responsibilities

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

Requirements

Bachelor's degree in Engineering required; 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

Nice to have

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

Benefits

Defined career path and annual performance review and feedback process; Diverse, inclusive culture; Potential for career growth on an expanding team; Competitive paid time off plus 8 paid holidays; Community engagement and green initiatives; Medical, dental, and vision benefits effective day one of employment; Tuition reimbursement