Automation Engineer, Biopharma Manufacturing

Automation Engineer Work Schedule: Monday – Friday, 8am – 5pm. 100% on-site. Position Summary Catalent’s Baltimore and Harmans, Maryland sites provide industry‑leading GMP development and manufacturing services for advanced biopharmaceuticals, including viral vectors, next‑generation vaccines, and oncolytic viruses. Our FDA‑licensed, state‑of‑the‑art Gene Therapy manufacturing campus in Harmans/BWI features two facilities located just five miles from BWI Airport and 13 miles from downtown Baltimore. The 200,000 sq. ft. Harmans/BWI‑1 facility includes 10 GMP suites, fill/finish operations, testing labs, and warehousing, while the 145,000 sq. ft. Harmans/BWI‑2 site under development will add 8 GMP suites and expanded cold storage. Together, the campus offers a dynamic environment at the center of Maryland’s biotechnology and research corridor. The Engineer, Automation will provide key support for various manufacturing systems, including Programmable Logic Controllers (PLC), OSI‑PI for Data Historian, Ignition for data reporting & remote alarms, and process equipment such as Single‑Use Bioreactors, Single‑Use Chromatography, Purification & Filtration systems, and other Original Equipment Manufacturer (OEM) systems in Manufacturing suites and QC labs. Under the direction of senior engineers, this role will troubleshoot challenging equipment and automation issues to improve manufacturing performance (e.g., yield improvements) and maintain the automation systems in compliance with cGMPs. Role Responsibilities Establish appropriate controls and administer the automated and computerized systems. Support a large‑scale capital project to develop and implement automation systems in a new manufacturing area, then continue support of those systems. Understand and support all GMPs, safety, and environmental regulations; periodically review automation documents, preventive and corrective maintenance, and SOPs to ensure compliance. Develop and support corrective actions for atypical automation situations. Use technical knowledge to assure efficient operation of a variety of automated processing and information technology systems; support installation and placement of new equipment into operations. Ensure compliance with FDA regulations, follow GAMP in task execution, including change control and deviation investigations; participate in audits and training programs for automated systems. Provide on‑floor support of manufacturing, process development, and laboratory activities. Maintain technical documentation (manuals, drawings, software, etc.). Provide client services support for business area applications. Offer technical support for plant downtime and automation‑related issues during after‑hours and weekends, as required, in accordance with the established coverage schedule. Perform other duties as assigned. Candidate Qualifications Associate’s degree in engineering, Information Technology, Science, or related field required; Bachelor’s preferred. Minimum 1 year of experience in an automation role supporting process, laboratory, or facility equipment; 2+ years preferred. Knowledge of bioprocess equipment (e.g., Single‑Use Bioreactors, Chromatography, Filtration) required. Experience with PLC programming and automation support in GMP environments preferred. Familiarity with OSI‑PI and Ignition systems preferred. Effective interpersonal and communication skills (written and oral) required. Position requires regular standing, walking, bending, and climbing; occasional lifting up to 30 lbs; manual dexterity to operate tools and equipment; clear visual inspection and documentation skills; and the ability to work in confined spaces or at a computer as needed, while adhering to all PPE and safety requirements. The anticipated salary range for this position in Maryland is $80,000 to $110,000 plus an annual bonus, when eligible. The final salary offered to a successful candidate may vary and will depend on several factors including type and length of experience, skillset, education, and business needs. Benefits Potential for career growth within an expanding team. Defined career path and annual performance review & feedback process. Cross‑functional exposure to other areas within the organization. Medical, Dental, Vision, and 401(k) benefits offered from day one of employment. 152 hours of PTO and 8 paid holidays. Opportunity to work on continuous improvement processes. Catalent is an Equal Opportunity Employer, including disability and veterans. #J-18808-Ljbffr Catalent