Senior Process Engineer - Engineering

Senior Process Engineer
Position Description
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 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, continuous improvement and CAPEX projects, etc.).
The Senior Process Engineerwill be responsible for the drafting and review of documentation, compilation, and assessment of process data, and providing technical input for deviation investigations, change controls, and CAPAs. This role is designed to be the SME of the processes in production. This position will be client facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward. This position will require some on-call and on-the-floor technical support to manufacturing.
This is a fulltime role working Days; Monday - Friday
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:

• Develop and execute technical work plans/schedules independently using customer milestones/and division/site performance standards and metrics. Review statement of work and ensure project stays within scope.
• Review technical documents for accuracy, thoroughness, and regulatory compliance.
• Train, coach, or mentor others on technical, development, or business topics.
• Participate in client meetings offering technical support project leadership and act as technical lead across multiple disciplines.
• Identify and recommend business opportunities on a project specific basis.
• Work 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.
• Participate in and support strategic alignment across Catalent Biologics sites and the Madison site.
• Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
• Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
• 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)
• Other during as assigned.

The Candidate:

• Associate' degree in a STEM discipline and 12 years related experience, OR
• Bachelor's degree in a STEM discipline and 6-9 years related experience, OR
• Master's degree in a STEM discipline and 4-6 years related experience, OR
• Doctorate Degree in a STEM discipline and 0-2 years related 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.
• Experience with statistical techniques for data analysis and reporting
• Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally
• Experience in investigating and closing deviations, OOS, and CAPAs
• Experience drafting and revising standard operating procedures, batch production records and reports
• Experience with operating and troubleshooting process equipment, including single-use systems and consumables
• Experience working on late phase, process performance qualification and commercial programs is a plus

Why you should join Catalent:

• Fast tracked career growth, with annual performance review and feedback process
• Competitive base salary with other compensation incentives including yearly incentive plan
• Medical, Dental, Vision, and 401K are all offered on day one of employment
• 19 days of Paid Time Off (152 hours PTO) + 8 paid holidays
• Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!
• Defined career path and annual performance review and feedback process

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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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.
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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