Senior Process Engineer - Equipment

Catalent•Harmans, MD

2d•Onsite

About The Position

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.

Requirements

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 cGMP regulations, sterile product compliance requirements, regulatory inspections, and domestic and international pharmaceutical engineering standards.
Proficiency in GMP documentation practices, including SOPs, batch records, calibration and maintenance records, change controls, technical reports, and other quality system documentation.
Strong problem-solving, continuous improvement, planning, and organizational skills with the ability to manage multiple priorities and adapt to changing manufacturing needs.
Effective written and verbal communication skills with a customer-focused, collaborative approach and the ability to work successfully across cross-functional teams.
Ability to perform the physical requirements of the role, including equipment inspections, tool and instrument operation, occasional lifting up to 40 pounds, work in confined spaces, use of PPE, and extended periods of standing, walking, or computer-based work.

Responsibilities

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.