Senior Process Engineer

Catalent Pharma Solutions; Maryland; On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid holidays (8)

Job summary

Catalent Pharma Solutions seeks a Senior Process Engineer for its Harmans, MD site to support biopharmaceutical manufacturing. You will own hands-on equipment maintenance, qualification, and commissioning, ensuring validated status while coordinating with cross-functional teams on optimization and tech transfers.

The role is 5–10 years of GMP experience with aseptic processes, focusing on liquid formulations in a cleanroom and single-use systems.

Qualifications

• Bachelor’s degree in Engineering required, chemical or mechanical preferred.
• 5–10 years of GMP-regulated biopharma maintenance/engineering experience.
• Experience with aseptic processes and fill/finish operations is a plus.

Responsibilities

• Provide hands-on bioprocess equipment SME support for manufacturing operations.
• Lead preventive maintenance, repairs, and commissioning activities (IQ/OQ).
• Collaborate with QA, MS&T, and operations to minimize downtime and optimize uptime.
• Prepare GMP documentation and support regulatory inspections as needed.

Skills

Bioprocess equipment

Maintenance experience

Troubleshooting

Regulatory knowledge

PPE safety

Education

Bachelor's degree in Engineering

Tools

CMMS

IQ/OQ testing

SCADA

Job description

About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

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.

Shift: Monday-Friday 8am-5pm
Location: Harmans, MD - BWI 100% Onsite

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.

The Candidate 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.

Pay

The anticipated salary range for this position in MD is $120,000 – $140,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• 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.
• Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
• Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Catalent is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.