Process Engineer

Process 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 Chelsea, MA is hiring a Process Engineer who is responsible for assisting senior engineering staff in the design and implementation of manufacturing processes, instrumentation and equipment for clinical and commercial manufacturing.  This individual assists in engineering design and process scale-up under the guidance of senior engineering staff.  She or he establishes operating equipment specifications and improves manufacturing techniques. The Process Engineer is involved in new product scale-up, process optimization, technology transfer and process validation activities.

This is a full-time on site salaried position. The core hours are Monday – Friday 8:00AM – 4:30PM EST

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

• Participates in the design, specification and installation of pharmaceutical manufacturing equipment;
• Participates in technology transfer and scale up activities;
• Provides plant floor support to manufacturing operations and personnel;
• Supports manufacturing and engineering operations by participating in the following: Draft and maintain Standard Operating Procedures and Batch Records, Production support, Process/equipment troubleshooting, Training of operators;
• Supports technical aspects of equipment/process investigations;
• Supports interdepartmental teams to facilitate product technology transfer from pilot plant to clinical manufacturing;
• Participates in manufacturing operations in problem solving with regards to equipment and systems;
• All other duties as assigned;

The Candidate

• Bachelor’s degree in Chemical Engineering (preferred), Mechanical Engineering, Pharmaceutical Sciences or related field required
• A minimum of 1+ years of relevant experience required
• Experience working in a FDA regulated operation, preferably in the pharmaceutical/biotechnology area
• Knowledge of Good Manufacturing Practice requirements required
• Demonstrated knowledge of equipment/process operating and design competencies preferred
• Strong process and mechanical hands-on capabilities required
• Ability to lead manufacturing operations during production runs
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 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 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