Job Abstract

Process Engineer MS&T

Summary:

The Process Engineer/Scientist provides technical support to Princeton, NJ Facility (CPNJ) Manufacturing processes in a GMP environment. Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process. The MSAT Process Engineer works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions. Other responsibilities include participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site. The MSAT process engineer works to identify and drive continuous improvements to the manufacturing process.

The Role:

• Functions as a technology and process subject matter expert.
• Provides on-the-floor and on-site technical support to manufacturing when necessary.
• Author, review and approve, as needed, various documents (eg. Batch records, SOPs).
• Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer).
• Analyze and summarize manufacturing data to support impact assessments and investigations.
• Owner of change controls for process and procedure changes.
• Lead and executes CAPA system investigations.
• Leads technology transfer efforts for new processes and product implementation.
• Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
• Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
• Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirement specifications, and participating on impact assessments.
• Ability to perform gowning activities and enter the manufacturing plant.
• Some travel will be required.

The Candidate:

• BSc and/or Advanced degree in Science or Chem/Bio Engineering
• Minimum 5 years of industry experience.
• Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support.
• Advanced degree(s) preferred.
• Scientific understanding in bioprocessing principles. Familiarity with cell therapy processes and cGMP is strongly preferred.
• Experience in Process qualification, validation
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus
• Experience with program management software and tools are a plus.
• Experience working with external parties and/or cross-functional teams.
• Experience interfacing with clients.
• Possess strong verbal/written communication skills and ability to influence at all levels.
• Ability to think strategically and to translate strategy into actions.
• Ability to prioritize tasks in a highly dynamic environment.

Position Benefits:

• 152 hours PTO & 8 Holidays
• Medical, Dental & Vision Benefits and 401k
• 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. 

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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