Senior Process Engineer - Equipment (Biopharma GMP, Onsite)

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 94,000 - 128,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

8 paid holidays

Job summary

Catalent Pharma Solutions’ Harmans, MD facility is seeking a Senior Process Engineer - Equipment to join a CGMP manufacturing team focused on introducing new biopharmaceutical products and single-use, cleanroom operations.

You will onboard new process equipment, lead commissioning and qualification, and coordinate with manufacturing, validation, and maintenance to ensure equipment is validated and reliable.

Qualifications

• Bachelor’s degree in Engineering (chemical or mechanical preferred).
• At least 4 years GMP/biopharma maintenance/engineering experience.
• Strong mechanical, electrical, and automation expertise.
• Experience with sterile manufacturing operations and aseptic filling equipment.
• Knowledge of cGMP regulations and quality systems.

Responsibilities

• Improve equipment reliability, quality, safety, maintenance, and manufacturing performance.
• Troubleshoot and optimize bioprocess, fill/finish, and lab equipment.
• Lead engineering projects from initiation through completion.
• Support scale-up, technology transfer, qualification, and validation activities.
• Coordinate with vendors, contractors, and cross-functional teams.
• Provide technical leadership and training to site personnel.

Skills

Troubleshooting

Equipment maintenance

Cross-functional collaboration

Project leadership

Education

Bachelor’s degree in Engineering

Chemical or Mechanical preferred

Tools

CMMS

SCADA

Validation protocols

Job description

Catalent Pharma Solutions’ Harmans, MD facility is seeking a Senior Process Engineer - Equipment to join a CGMP manufacturing team focused on introducing new biopharmaceutical products and single-use, cleanroom operations.

You will onboard new process equipment, lead commissioning and qualification, and coordinate with manufacturing, validation, and maintenance to ensure equipment is validated and reliable.