Automation Engineer II

Catalent•Chelsea, MA

12d•Onsite

About The Position

Automation Engineer II Position Summary: Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is hiring an Automation Engineer II. The Automation Engineer II is expected to assist senior engineering staff in the design and implementation of automation systems for clinical and commercial manufacturing. The candidate provides support in automation engineering, design, and validation. The Automation Engineer II contributes to the design and implementation of new control systems to achieve cost effectiveness and robust manufacturing. This individual provides on-going technical support, including the maintenance, installation, startup, commissioning, testing, and qualification of automation systems. This is a full-time salaried on-site role on 1st shift: Monday-Friday with expected hours of 8am-5pm, although overtime may be required depending on production needs. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

Requirements

Bachelor’s degree in Engineering required, preferably in Chemical or Electrical Engineering
Must have at least two years of relevant automation experience
Experience with Rockwell/Allen-Bradley batch control systems or equivalent is required.
Requires knowledge of: pharmaceutical process equipment and Clean In Place (CIP) systems, ANSI/ISA-88 Batch Control Standard, Allen Bradley/Rockwell FactoryTalk Process Control System, and relational databases and process automation protocols
Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds

Nice To Haves

Experience with other control systems (Siemens, Schneider, etc.) is preferred
Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field

Responsibilities

Assists or leads the design, specification, and installation of pharmaceutical manufacturing automation systems.
Participates in automation expansion and upgrade projects
Performs and documents hardware/software modifications to existing systems
Ensures that all automation designs and technical documentation adhere to GMP standards.
Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements
Prepares standard operating procedures for new and existing control equipment
Trains users on control system functionality (Programmable Logic Controller, Computer/Control Networks, Control Computers and Instrumentation)
Troubleshoots and diagnoses control system problems, working closely with maintenance, control technicians, and metrology
Supports software lifecycle, and electronic records/electronic signature compliance efforts.
Supports change controls and technical aspects of control equipment investigations, as applicable
All other duties as assigned

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 Hours + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Company match on donations to organizations
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement – Let us help you finish your degree or start a new degree!
WellHub program to promote overall physical wellness
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