GMP Facilities Engineer – Biotech Utilities

Catalent; Harmans (MD); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

Paid time off and holidays

Career development

Diversity and inclusion

Job summary

Catalent's Harmans, MD facility seeks an Engineer, Facilities to provide engineering support for critical utilities in GMP manufacturing. You will collaborate with Facilities, Engineering, and Manufacturing to design, scale, and enhance manufacturing capabilities, ensuring reliable utility systems that support patient-critical manufacturing.

The role involves advising on design, documentation, FAT/SAT/IQ/OQ/PQ testing, and addressing deviations.

Qualifications

• Bachelor's degree in Chemical/Biochemical/Mechanical Engineering or related field with at least 2 years of related experience.
• Knowledge of cGMP manufacturing and regulatory requirements for biologics/pharma.
• Excellent problem-solving skills and ability to work with minimal supervision.
• Understanding of Clean Utility Systems including WFI, purified water, clean steam, HVAC, clean gas.
• Proficient in MS Office (Excel and Word) and able to document technical data.
• Ability to communicate in written and verbal English.
• Ability to prepare authoritative reports and presentations.
• Physical ability to work in a GMP environment and lift up to 30 pounds.

Responsibilities

• Advise on design, implementation, and commissioning for new and modified utility equipment within GMP facilities.
• Prepare protocols, SOPs, and assessments for engineering changes and validation activities.
• Create design specs, P&ID, GA drawings, and functional specifications with cross-functional teams.
• Write FAT/SAT/IQ/OQ/PQ documentation and review testing protocols.
• Propose solutions for equipment problems and evaluate multiple options.
• Investigate manufacturing deviations and anomalies related to facility systems.
• Perform utility monitoring, capability analysis, and quality engineering activities.
• Perform other duties as assigned.

Skills

Problem solving

Communication in English

Detail oriented

MS Office (Excel, Word)

cGMP knowledge

Education

Bachelor of Science in Chemical, Biochemical, or Mechanical Engineering or related field

Job description

Catalent's Harmans, MD facility seeks an Engineer, Facilities to provide engineering support for critical utilities in GMP manufacturing. You will collaborate with Facilities, Engineering, and Manufacturing to design, scale, and enhance manufacturing capabilities, ensuring reliable utility systems that support patient-critical manufacturing.

The role involves advising on design, documentation, FAT/SAT/IQ/OQ/PQ testing, and addressing deviations.