Process Engineer - MS&T Operational Engineering

Sunday to Wednesday 1st shift

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.

Our new, state-of-the-art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

The Manufacturing Sciences and Technology (MS&T) department’s primary function is to serve as an agile technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, enzymes, mRNA, new modalities, etc.), process readiness and execution support related to documentation, equipment, consumables and materials, and technical writing. The MS&T organization supports the Madison facility as well as the Catalent Biologic’s network through client-facing support, on-the-floor or on-call technical coverage, as well as continuous improvement and site strategy projects.

The Operational Engineering group primary function is to provide technical support for the manufacturing execution team. This includes on the floor or on-call support during execution. The team will be the subject matter experts on the manufacturing process and equipment and provide input in the design of consumables and batch records/SOPs to support operational success.

This is a full-time role working Sunday to Wednesday 1st shift (5am-4pm)

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:

• Support technology transfer of processes into manufacturing for both internally and externally developed processes.

• Works cross-functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities and other departments to effectively transfer and maintain processes in the facility.

• Works closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.

• Leads and/or supports the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.

• Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.

• Authors and reviews documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.

• Acts 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.

• Other duties as assigned.

The Candidate:

• MS. in engineering, biotechnology, or a related field with at 0 to 2 years of biopharmaceutical process development and/or manufacturing experience

• BS/BA in engineering, biotechnology, or a related field with 3 to 6 years of biopharmaceutical process development and/or manufacturing experience

• Associate degree in a related field with at least 6 to 9 years of biopharmaceutical process development and manufacturing experience

• Experience with Upstream (mammalian cell culture), Downstream (chromatography, tangential flow filtration, etc.) and/or molecular therapeutics (mRNA or new modality) processes across cGMP production scales

• Experience with design, onboarding, qualification and troubleshooting biologics/molecular therapeutics single-use consumables and/or manufacturing equipment

• Advanced in core techniques. Advanced understanding of instrument operations and troubleshooting skills in multiple techniques.

• Strong technical knowledge and hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment.

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

• 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 (https://careers.catalent.com/us/en) 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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