Engineer, Automation

Catalent Pharma Solutions•Glen Burnie, MD

10d•$80,000 - $110,000•Onsite

About The Position

The Engineer, Automation provides support for manufacturing automation and computerized systems at Catalent’s Baltimore and Harmans, Maryland sites, which provide GMP development and manufacturing services for advanced biopharmaceuticals. The role supports programmable logic controllers (PLCs), OSI-PI data historian, IGNITION data reporting and remote alarms, process equipment such as single-use bioreactors, chromatography, purification and filtration systems, and other OEM systems used in manufacturing suites and QC labs. Under the direction of senior engineers, the Engineer troubleshoots challenging equipment and automation issues, helps improve manufacturing performance, and maintains systems in compliance with cGMPs. The position also supports a large-scale capital project to develop and implement automation systems in a new manufacturing area, followed by ongoing support of those systems. It provides on-floor technical support for manufacturing, process development, and laboratory activities; supports installation and operation of new equipment; maintains technical documentation; and provides business-area application support. The role follows FDA regulations and GAMP practices, including change control and deviation investigations, and participates in audits and training. After-hours and weekend support for plant downtime and automation issues may be required according to the coverage schedule. The schedule is Monday through Friday, 8 a.m. to 5 p.m., and the position is 100% on-site. The work requires regular standing, walking, bending, and climbing; occasional lifting 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 demands of the position, including regular standing, walking, bending, and climbing; occasional lifting up to 30 pounds; manual dexterity to operate tools and equipment; visual inspection and documentation; and work in confined spaces or at a computer as needed.
Adherence to PPE and safety requirements.

Nice To Haves

Bachelor’s degree.
At least 2 years of experience in an automation role supporting process, laboratory, or facility equipment.
Experience with PLC programming and automation support in GMP environments.
Familiarity with OSI-PI and IGNITION systems.

Responsibilities

Establish controls and administer automated and computerized systems.
Support the development and implementation of automation systems for a new manufacturing area and provide continued support after implementation.
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 for operational use.
Ensure compliance with FDA regulations and follow GAMP practices, including change control and deviation investigations.
Participate in audits and training programs for automated systems.
Provide on-floor support for manufacturing, process development, and laboratory activities.
Maintain technical documentation, including manuals, drawings, and software documentation.
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 coverage schedule.
Perform other duties as assigned.