Engineer, Facilties

Catalent•Harmans, MD

1d•$80,000 - $110,000•Onsite

About The Position

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

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.

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 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.