Senior Process Engineer - Equipment

Senior Process Engineer
- Equipment

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.

We have an opportunity for a Senior Process Engineer
- Equipment to join our team. This role focuses on introducing a new suite of biopharmaceutical products at our development and manufacturing sites. You will work with liquid formulations under a single-use production concept in a cleanroom environment. The position involves onboarding new process equipment, preparing and executing commissioning and qualification protocols, and coordinating with other departments to ensure validated status of equipment.

This is a full-time role for an ambitious, hands-on engineer eager to contribute to an expanding CDMO.

Shift: Monday
- Friday, 8am-5pm

Location:

Harmans, MD - BWI 100% Onsite

• Analyze, develop, and implement engineering solutions to improve equipment reliability, quality, safety, maintenance, and manufacturing performance.
• Troubleshoot, repair, and optimize bioprocess, fill/finish, packaging, laboratory, and utility equipment, instrumentation, and control systems.
• Serve as the engineering subject matter expert (SME) for upstream, downstream, fill/finish, and packaging operations.
• Lead engineering projects from initiation through completion, including planning, documentation, scheduling, contractor oversight, and stakeholder communication.
• Support process scale-up, technology transfer, commissioning, qualification, and validation activities through risk assessments, root cause investigations, and gap analyses.
• Manage preventive and corrective maintenance programs using CMMS, including work orders, SOP development, spare parts strategies, and equipment lifecycle documentation.
• Execute and support GMP-compliant quality systems activities, including change controls, deviations, CAPAs, document revisions, and failure investigations.
• Collaborate cross-functionally with manufacturing, facilities, validation, MS&T, automation, laboratory, and maintenance teams to maximize equipment uptime and operational efficiency.
• Partner with automation engineers to support SCADA integration, controls systems, and equipment automation initiatives.
• Develop engineering specifications, technical reports, drawings, equipment history files, and other required engineering documentation.
• Provide technical leadership, training, mentoring, and project guidance to engineers, mechanics, operators, and other site personnel while supporting regulatory inspections.
• Coordinate with vendors, contractors, purchasing, and network sites to support maintenance, repairs, procurement activities, and site-wide engineering initiatives, including off-shift or weekend support as needed.

• Bachelor's degree or higher in Engineering (chemical or mechanical engineering preferred).
• At least 4 years of related work experience in GMP or biopharma maintenance/engineering.
• Strong mechanical, electrical, and automation engineering expertise with the ability to troubleshoot, repair, and maintain bioprocess equipment, instrumentation, and process control systems.
• Experience supporting sterile manufacturing operations, including aseptic filling equipment, isolator technology, and biopharmaceutical equipment throughout its lifecycle from design and qualification to maintenance.
• Working knowledge of…