Process Engineer

Engineer – Process Engineering

Summary

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market-leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world-class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Equipment Engineering group has oversight of equipment lifecycle management inclusive of equipment design (URS through qualification support and release), equipment updates (design modifications via change management), and general equipment support through troubleshooting, training, and continuous improvement. This function also maintains ownership of the capital expenditure (CapEx) process.          

The Process Engineering group has oversight of consumable and raw material lifecycle management inclusive of process function definition, design through drawing approval, onboarding support, and change management. This function ensures integration of consumables with equipment and associated manufacturing processes, while maintaining larger strategy project ownership across the facility (e.g., equipment methods, risk assessments, control strategies, etc.).

This is a full-time on-site position, Monday – Friday 8am-5:00pm.

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:

• Evaluate existing processes and identifies process or equipment improvements to advance efficiency, cost savings, time savings, consistency, and competitiveness within the market.
• Support the building of business case(s) for process improvement projects.
• Author and review documents including bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
• Support drafting and development of User Required Specifications, support and attend Factory Acceptance Testing, Site Acceptance Testing, Qualification/Validation testing for existing and new technologies.
• Lead site strategy projects with dedicated cross-department resources with Site Leadership (SLT) visibility through implementation.
• Oversee technical support of Manufacturing, including change management (consumable lifecycle integration with site equipment, raw materials), SME troubleshooting, and leading or providing oversight on site strategy projects.
• Work alongside a group of engineers, scientists, and other colleagues to oversee the process engineering function associated with mammalian biologic processes, mRNA, and other new modality manufacturing.
• Support biologics/molecular therapeutics drug substance consumable and raw material lifecycle management from identification and/or design through implementation for single-use GMP manufacturing (fit for process use).
• Track, trend, and analyze data for compliance, product quality, continuous improvement, and day-to-day investigations/troubleshooting activities.
• Other duties as assigned.

The Candidate:

• Minimum B.S. degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 3+ years' facilities operation/automation engineering experience in a cGMP environment (preferably biopharmaceutical) OR
• M.S. degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 1+ years' facilities operation/automation engineering experience in a cGMP environment (preferably biopharmaceutical)  
• Previous experience leading cross-department facility and/or site improvement projects, a plus
• Problem-solving (Lean Six Sigma) and change management methodologies consistent with a culture of continuous improvement is preferred
• Must be proficient in operation and troubleshooting of a wide variety of instrumentation and data systems
• Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify, and transfer methods accordingly
• Ability to cross-train on techniques across multiple groups.
• Experience writing, editing, and reviewing Standard Operating Procedures preferred

Physical Requirements:

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Occasional stooping, kneeling, crouching, bending, carrying, grasping.
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
• Must comply with EHS responsibilities for the position.
• Working conditions will be Heating Ventilation and Air Conditioned controlled.
• Ability to operate within a clean room environment as needed.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of paid time off annually + 8 paid holidays 
• Competitive salary with yearly bonus potential 
• Community engagement and green initiatives 
• Generous 401K match and Paid Time Off accrual 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement 

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 international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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