Onsite Senior Bioprocess Engineer – GMP Biotech

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off

8 paid holidays

Job summary

Catalent Pharma Solutions in Harmans, MD is seeking a Senior Process Engineer to lead biopharmaceutical equipment onboarding, IQ/OQ, and maintenance in a 100% onsite role at a GMP facility. You will troubleshoot bioreactors, fermenters, chromatography skids, and fill/finish utilities, coordinating with MS&T, Quality, and vendors to minimize downtime.

Ideal candidates have 5–10 years of GMP biopharma experience, a B.E.

Qualifications

• Bachelor’s degree in Engineering required; Chemical or Mechanical preferred.
• 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.

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.

Skills

Bioprocess equipment

Maintenance experience

cGMP compliance

Mechanical engineering

Aseptic processing

Troubleshooting

Vendor coordination

Education

Bachelor's degree in Engineering

Tools

CMMS

SCADA

IQ/OQ

Job description

Catalent Pharma Solutions in Harmans, MD is seeking a Senior Process Engineer to lead biopharmaceutical equipment onboarding, IQ/OQ, and maintenance in a 100% onsite role at a GMP facility. You will troubleshoot bioreactors, fermenters, chromatography skids, and fill/finish utilities, coordinating with MS&T, Quality, and vendors to minimize downtime.

Ideal candidates have 5–10 years of GMP biopharma experience, a B.E.