Senior Automation Engineer

Senior Automation Engineer

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 a Senior Automation Engineer. The Senior Automation Engineer is expected to be a subject matter expert, responsible for the design and implementation of automation systems for clinical and commercial manufacturing. The candidate provides expertise in automation engineering, design, and validation. The Senior Automation Engineer leads 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 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. 

The Role:

• Provides engineering expertise for the design, specification, and installation of pharmaceutical manufacturing automation systems. Leads automation portion of expansion and upgrade projects
• Performs and documents hardware/software modifications to existing systems. Ensures that all automation designs and technical documentation adhere to Good Manufacturing Practices (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

The Candidate:

• Bachelor’s degree in Chemical, Electrical or Mechanical Engineering required
• Must have at least eight years of relevant automation experience
• Experience with Rockwell/Allen-Bradley batch control systems or equivalent is required. Experience with other control systems (Siemens, Schneider, etc.) is preferred
• 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
• Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field
• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds

Why you should join Catalent:

• 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 dedica