Senior Process Engineer - Equipment

Catalent•Harmans, MD

9d•$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 work involves liquid formulations using a single-use production concept in a cleanroom environment, onboarding new process equipment, preparing and executing commissioning and qualification protocols, and coordinating with other departments to ensure equipment reaches validated status. The engineer develops and implements solutions to improve equipment reliability, quality, safety, maintenance, and manufacturing performance. The role serves as an engineering subject matter expert across upstream, downstream, fill/finish, and packaging operations; leads equipment and engineering projects; supports scale-up, technology transfer, commissioning, qualification, and validation; and manages maintenance and GMP quality-system activities. It also involves cross-functional collaboration, technical documentation, automation support, technical leadership, and coordination with vendors and contractors. This is a full-time, 100% onsite position at the Harmans, Maryland BWI campus, Monday through Friday, 8 a.m. to 5 p.m. The posting lists an anticipated Maryland salary range of $94,000–$128,000, plus bonus; the final offer may vary based on factors including experience, skills, education, and business needs.

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, including 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 and a customer-focused, collaborative approach, including the 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.

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 to support 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 while supporting 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.
Onboard new process equipment and prepare and execute commissioning and qualification protocols in coordination with other departments.