Engineer, Facilities

Position Summary

Provide engineering support for critical utilities in GMP manufacturing. Collaborate with Facilities, Engineering, and Manufacturing teams to design, scale, and enhance manufacturing capabilities and operations. Ensure reliable utility systems that support patient-critical manufacturing. Advise on the selection, implementation, and modification of utility equipment and related systems.

The Role

• Advise on design, implementation, and commissioning for 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, standard operating procedures, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to qualification and validation to meet regulatory requirements for facility and utility systems.
• Work with industry consultants to create design specifications, Piping and Instrumentation Diagrams (P&ID), General Arrangement (GA) drawings, User Requirements, Functional Specifications, and automation control strategies.
• Drive standardization within the department and company.
• Write and review technical documentation such as protocols and reports for Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and Installation/Operational/Performance Qualification (IQ/OQ/PQ) testing.
• Provide technical solutions to facility and utility equipment problems, develop reports evaluating multiple solutions, share findings, and make recommendations for resolution.
• Perform investigations of manufacturing deviations and anomalies related to failure of facility systems.
• Perform utility monitoring, utility capability, statistical analysis, and quality engineering activities.
• Other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor of Science or Bachelor of Arts in Chemical, Biochemical, or Mechanical Engineering, or related field with 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.
• Excellent problem-solving skills and ability to work in collaborative and independent environments with minimal supervision.
• In-depth understanding and knowledge of Clean Utility Systems including Water for Injection (WFI) generation and distribution, purified water generation and distribution, clean steam generation and distribution, HVAC for clean rooms, clean gas generation and distribution.
• Ability to communicate in written and verbal English.
• Ability to formulate complex and comprehensive materials such as authoritative reports and make formal presentations.
• Detail-oriented with ability to work effectively under high pressure with multiple deadlines.
• Experienced in all aspects of method lifecycle support and able to develop strategies and tactics to meet regulatory milestones.
• Proficient in the use of MS Office, specifically MS Excel and MS Word, as well as programs for multiple pieces of laboratory equipment.
• Must be able to stand, walk, bend, climb stairs and ladders, and work in occasionally confined or awkward spaces throughout the day.
• The role requires the ability to lift and carry up to 30 pounds occasionally, use manual dexterity to operate tools, instruments, laptops, and measurement equipment, and visually inspect equipment, read instruments, and review documentation with accuracy (corrected vision acceptable).
• Employees must also be able to sit for extended periods while preparing documentation, reports, and data analyses and wear required personal protective equipment (PPE), including lab coats, gloves, safety glasses, and respiratory protection when necessary.

Preferred Skills & Background

• 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).