Process Engineer, MS&T

Position Summary:

Catalent Pharma Solutions in Princeton, NJ is hiring a Manufacturing Science and Technology (MSAT) Process Engineer who 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

This is a full-time role position: Monday – Friday, days.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent’s cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium. The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production

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

• 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;

• All other duties as assigned;

The Candidate

• Bachelors and/or Advanced degree required in Science or Chemical/Biological Engineering with 5+ years of industry experience required;

• 3+ years relevant experience in GMP biologic/cell therapy manufacturing technical or process support;

• Scientific understanding in bioprocessing principles. Familiarity with cell therapy processes and cGMP is strongly preferred;

• Experience in process qualification and validation required;

• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is preferred;

• Experience with program management software and tools preferred;

• Experience working with external parties and/or cross-functional teams

• Ability to think strategically and to translate strategy into actions

• 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

• 152 Hours PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Employee Stock Purchase Program

• 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

• Competitive salary with 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 – Let us help you finish your degree or earn a new one!

• GymPass program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .