Engineer, Automation

Catalent•Harmans, MD

3d•$80,000 - $110,000•Onsite

About The Position

The Engineer, Automation supports manufacturing systems at Catalent’s Baltimore and Harmans, Maryland sites, including programmable logic controllers (PLCs), OSI-PI data historian, IGNITION data reporting and remote alarms, single-use bioreactors, chromatography, purification and filtration systems, and other OEM systems in manufacturing suites and QC labs. Under the direction of senior engineers, the role troubleshoots challenging equipment and automation issues to improve manufacturing performance and maintains automation systems in compliance with cGMP requirements. The position also supports a large-scale capital project to develop and implement automation systems in a new manufacturing area, followed by continued support of those systems. It provides on-floor support for manufacturing, process development, and laboratory activities, as well as technical support for plant downtime and automation-related issues after hours and on weekends when required by the established coverage schedule. The work schedule is Monday through Friday, 8 a.m. to 5 p.m., and the position is 100% on-site. The role requires regular standing, walking, bending, and climbing; occasional lifting of up to 30 pounds; manual dexterity; visual inspection and documentation; and the ability to work in confined spaces or at a computer while following PPE and safety requirements.

Requirements

Associate’s degree in engineering, Information Technology, Science, or a related field.
At least 1 year of experience in an automation role supporting process, laboratory, or facility equipment.
Knowledge of bioprocess equipment, such as single-use bioreactors, chromatography, and filtration.
Effective written and oral interpersonal and communication skills.
Ability to meet the physical requirements of the position, including regular standing, walking, bending, and climbing; occasional lifting up to 30 pounds; manual dexterity; visual inspection and documentation; and working in confined spaces or at a computer as needed while adhering to PPE and safety requirements.

Nice To Haves

Bachelor’s degree.
At least 2 years of relevant automation experience.
Experience with PLC programming and automation support in GMP environments.
Familiarity with OSI-PI and IGNITION systems.

Responsibilities

Establish appropriate controls and administer automated and computerized systems.
Support a large-scale capital project to develop and implement automation systems in a new manufacturing area and provide ongoing support for those systems.
Support GMP, safety, and environmental requirements; periodically review automation documents, preventive and corrective maintenance, and SOPs for compliance.
Develop and support corrective actions for atypical automation situations.
Use technical knowledge to support efficient operation of automated processing and information technology systems.
Support installation and commissioning of new equipment into operations.
Ensure compliance with FDA regulations and follow GAMP in task execution, including change control and deviation investigations.
Participate in audits and training programs for automated systems.
Provide on-floor support to manufacturing, process development, and laboratory activities.
Maintain technical documentation, including manuals, drawings, and software.
Provide client services support for business-area applications.
Provide technical support for plant downtime and automation-related issues after hours and on weekends as required by the established coverage schedule.
Perform other duties as assigned.