Senior Bioprocess Engineer - GMP Equipment Expert (Onsite)

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

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.