Senior Process Engineer - Equipment

Senior Process Engineer - Equipment About Site 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. Position Summary 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 The Role 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. The Candidate Minimum 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. Pay The anticipated salary range for this position in MD is $94,000 – $128,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why You Should Join Catalent Defined career path and annual performance review and feedback process. Diverse, inclusive culture. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Competitive paid time off plus 8 paid holidays. Community engagement and green initiatives. Medical, dental, and vision benefits effective day one of employment. Tuition reimbursement. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. 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