Catalent
Harmans, MD
Shift: Full time
Automation Engineer Position Summary: Work Schedule: Monday – Friday, 8am – 5pm. 100% on-site 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. This will include Programmable Logic controllers (PLC), OSI-PI for Data Historian, IGNITION for data reporting remote alarms, process equipment such as Single-Use (SU) Bioreactors, SU Chromatography, Purification Filtration systems, and Other Original Equipment Manufacturer (OEM) systems in Manufacturing suites and QC labs. Under the direction of the senior engineers, this role will be responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. yield improvements, etc.) and maintaining the automation systems in compliance with cGMPs. The Role Establish the appropriate controls and administrate the automated and computerized systems Support of a large-scale capital project to develop and implement automation systems in a new manufacturing area, then continued support of those systems as described throughout the description Understand and support all GMPs, safety, and environmental regulations. Periodically reviews automation documents, preventive and corrective maintenance, and SOPs to ensure compliance with GMP and safety. On atypical automation situations, develops and supports corrective actions. Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Supports installing and placing new equipment into operations. Ensures compliance to FDA regulations and follows GAMP in task execution, including change control and deviation investigations. Participates in audits and training programs for automated systems On-floor support of manufacturing, process development and laboratory activities. Maintain technical documentation (manuals, drawings, software, etc.). Provides 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 Other duties as assigned. The Candidate 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., SU 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) are 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 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 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 401K are all offered from day one of employment. 152 hours of PTO and 8 paid holidays. Opportunity to work on Continuous Improvement Processes 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 em