Engineer, Automation

Catalent Pharma Solutions•Harmans, MD

29d•$80,000 - $110,000•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Experience with PLC programming and automation support in GMP environments preferred
Familiarity with OSI-PI and IGNITION systems preferred.

Responsibilities

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.