Engineer, Facilties

Catalent Pharma Solutions•Glen Burnie, MD

27d•$80,000 - $110,000•Onsite

About The Position

Catalent is hiring an Engineer, Facilities to provide engineering support for critical utilities in GMP manufacturing at its Harmans/BWI campus in Harmans, Maryland. The role collaborates with Facilities, Engineering, and Manufacturing teams to design, scale, and enhance manufacturing capabilities and operations, ensuring reliable utility systems that support patient-critical manufacturing. The engineer advises on selecting, implementing, and modifying utility equipment and related systems to meet the evolving needs of the GMP manufacturing facility while maintaining quality, safety, and regulatory standards. The position is 100% onsite and scheduled Monday through Friday, 8:00 a.m. to 5:00 p.m. The campus supports Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines. Responsibilities include utility-system design and commissioning support; technical documentation and change assessments; development and review of engineering drawings, specifications, and automation strategies; qualification and validation testing; troubleshooting and investigation of facility-system issues; and utility monitoring and quality engineering activities.

Requirements

Bachelor of Science or Bachelor of Arts in Chemical, Biochemical, or Mechanical Engineering, or a related field.
At least 2 years of related experience supporting manufacturing.
Working knowledge of current Good Manufacturing Practice (cGMP) manufacturing and regulatory requirements for biologics and pharmaceuticals.
Strong problem-solving skills and ability to work collaboratively and independently with minimal supervision.
In-depth knowledge of clean utility systems, including Water for Injection (WFI) generation and distribution, purified water generation and distribution, clean steam generation and distribution, clean-room HVAC, and clean gas generation and distribution.
Ability to communicate in written and verbal English.
Ability to formulate complex, comprehensive materials such as authoritative reports and make formal presentations.
Detail-oriented, with the ability to work effectively under pressure and manage multiple deadlines.
Experience in all aspects of method lifecycle support and ability to develop strategies and tactics to meet regulatory milestones.
Proficiency with MS Office, specifically Excel and Word, as well as programs for multiple pieces of laboratory equipment.
Ability to stand, walk, bend, climb stairs and ladders, and work in occasionally confined or awkward spaces throughout the day.
Ability to lift and carry up to 30 pounds occasionally; use manual dexterity to operate tools, instruments, laptops, and measurement equipment; visually inspect equipment, read instruments, and accurately review documentation; sit for extended periods; and wear required PPE, including lab coats, gloves, safety glasses, and respiratory protection when necessary.

Nice To Haves

Experience in the biotech or pharmaceutical industry.
Understanding of biochemical and molecular assays (ddPCR, qPCR, ELISA), cell-based assays (infectivity, potency), and separation assays (HPLC, CE-SDS).

Responsibilities

Advise on the design, implementation, and commissioning of new utility equipment and modifications to existing utility equipment and facilities within GMP Manufacturing while maintaining company quality and safety standards.
Author and review protocols and standard operating procedures, and provide technical assessment and approval for engineering and process changes and qualification and validation documentation to meet regulatory requirements for facility and utility systems.
Work with industry consultants to create design specifications, Piping and Instrumentation Diagrams (P&IDs), General Arrangement (GA) drawings, User Requirements, Functional Specifications, and automation control strategies.
Drive standardization within the department and company.
Write and review technical documentation, including protocols and reports for Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and Installation/Operational/Performance Qualification (IQ/OQ/PQ) testing.
Develop technical solutions to facility and utility equipment problems, evaluate multiple solutions, report findings, and recommend resolutions.
Investigate manufacturing deviations and anomalies related to facility-system failures.
Perform utility monitoring, utility capability, statistical analysis, and quality engineering activities.
Perform other duties as assigned.