Engineer, Automation

Location: Harmans

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…