Senior Process Engineer - Equipment

Catalent Pharma Solutions•Glen Burnie, MD

6d•$94,000 - $128,000•Onsite

About The Position

The Senior Process Engineer - Equipment joins Catalent’s Harmans/BWI team to introduce a new suite of biopharmaceutical products at development and manufacturing sites. The role works with liquid formulations using a single-use production concept in a cleanroom environment. It involves onboarding process equipment, preparing and executing commissioning and qualification protocols, and coordinating across departments to establish validated equipment status. The engineer develops and implements solutions to improve equipment reliability, quality, safety, maintenance, and manufacturing performance. The role supports equipment and systems across bioprocessing, fill/finish, packaging, laboratories, and utilities, and provides technical leadership across engineering projects and GMP quality activities. It is a full-time, 100% onsite position in Harmans, Maryland, with a Monday–Friday, 8 a.m.–5 p.m. schedule; off-shift or weekend support may be needed.

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 or engineering.
Strong mechanical, electrical, and automation engineering expertise, including 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; ability to manage multiple priorities and adapt to changing manufacturing needs.
Effective written and verbal communication skills, a customer-focused and collaborative approach, and ability to work successfully across cross-functional teams.
Ability to perform equipment inspections and operate tools and instruments; occasionally lift up to 40 pounds; work in confined spaces; use PPE; and spend extended periods standing, walking, or working at a computer.

Nice To Haves

Chemical or mechanical engineering degree.
Experience with single-use production concepts and liquid formulations in a cleanroom environment.

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 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 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 system activities, including change controls, deviations, CAPAs, document revisions, and failure investigations.
Collaborate with manufacturing, facilities, validation, MS&T, automation, laboratory, and maintenance teams to maximize equipment uptime and operational efficiency.
Partner with automation engineers on SCADA integration, control 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, and support regulatory inspections.
Coordinate with vendors, contractors, purchasing, and network sites on maintenance, repairs, procurement, and site-wide engineering initiatives, including off-shift or weekend support as needed.