Process Engineer MS&T

Catalent Pharma Solutions; Princeton (KY); On-site; USD 105,000 - 125,000; Full time

Benefits offered by this job

Medical benefits

Tuition reimbursement

Paid time off

Holidays

Job summary

Catalent's Princeton, NJ site is a key part of the company's cell therapy network and supports manufacturing across the product lifecycle. The Process Engineer MS&T will lead tech transfer, qualification, and lifecycle activities to ensure robust, compliant cell therapy processes.

The role reports to the MS&T Manager and involves hands-on support, data analysis, and collaboration with Manufacturing, Process Development, Engineering, and Quality teams to enable reliable, scalable production and

Qualifications

• Bachelor of Science in Science or Chemical/Biological Engineering.
• Minimum 5 years in industry, with 3 years in cGMP biologic or cell therapy manufacturing.
• Strong knowledge of FDA cGMP regulations (21 CFR Parts 11, 210, 211).
• Experience with equipment qualification, process validation, and compliant operations.
• Excellent collaboration and communication across cross-functional teams.

Responsibilities

• Lead MS&T processes during technology transfer and lifecycle management.
• Assess readiness for new programs via fit-gap analyses and risk reviews.
• Author and approve cGMP documents, batch records, SOPs, and reports.
• Lead process validation and ongoing monitoring with CAPA and deviations.
• Analyze data to support process understanding and improvements.
• Collaborate with Manufacturing, Supply Chain, Process Development, and Engineering.

Skills

Bioprocessing

Regulatory knowledge

Communication skills

Data analysis

Problem solving

Education

B.S. in Chemical/Biological Engineering

Advanced degree

Tools

Data Historian

Distributed Control Systems

Autoclaves

Job description

Process Engineer MS&T

About Site

Catalent’s Princeton, New Jersey site is a key part of the company’s cell therapy network and serves as a U.S. commercial manufacturing facility for autologous and allogeneic cell therapies. The site is equipped to support the full product lifecycle, including late‑stage clinical development, process characterization, and commercial‑scale CGMP manufacturing across a wide range of cell types. With flexible cleanroom suites, quality control laboratories, and an experienced technical team focused on scalable, single‑use manufacturing approaches, the Princeton site enables reliable production and supply of advanced cell‑based therapies. As part of Catalent’s global Cell & Gene Therapy organization, the Princeton facility plays a strategic role in helping partners advance complex, personalized medicines toward commercialization.

Position Summary

We have an opportunity for a Process Engineer MS&T to join our team and provide technical leadership and support to our Princeton, NJ cGMP manufacturing facility. This role ensures cell therapy processes are robust, scalable, and compliant with cGMP standards. You will drive seamless technology transfer, reliable manufacturing, and continuous improvement to deliver safe, high-quality therapies to patients. The position reports to the Manager, MS&T and plays a key role in operational excellence and innovation.

Shift: Monday - Friday, 8:00am - 4:30pm
Location: Princeton, NJ
100% Onsite

The Role

• Serve as the Manufacturing Science & Technology (MS&T) process subject matter expert, leading technology transfer, new product introduction, and lifecycle management activities.
• Evaluate facility, equipment, process, and workflow readiness through fit-gap analyses, risk assessments, and manufacturing feasibility reviews for new programs.
• Author, review, and approve cGMP technical documentation, including batch records, SOPs, protocols, validation documents, sample plans, and technical reports.
• Lead process validation activities, including validation strategy development, PPQ support, regulatory compliance, and ongoing process monitoring.
  Provide hands-on manufacturing support through process troubleshooting, deviation management, root cause investigations, quality event triage, and CAPA implementation.
• Analyze, trend, and interpret manufacturing data using statistical and data-driven methodologies to support process understanding and performance improvements.
• Identify and implement process optimizations, operational efficiencies, and new technologies to enhance productivity, quality, and compliance.
• Partner with Manufacturing, Supply Chain, Process Development, and
• Engineering teams to support equipment implementation, material assessment, validation, and operational readiness.
• Represent MS&T as a technical expert on cross-functional and client-facing project teams, maintaining effective relationships with vendors and stakeholders.
• Support site performance objectives related to quality, delivery, cost, and safety while contributing to employee training and technical development initiatives.
• Other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor of Science in Science or Chemical/Biological Engineering.
• Minimum 5 years of industry experience, including 3 years in cGMP biologic or cell therapy manufacturing, technical, or process development roles.
• Strong scientific understanding of bioprocessing principles.
• Strong knowledge of FDA cGMP regulations (21 CFR Parts 11, 210, and 211) and their application to manufacturing facilities, equipment, systems, and processes.
• Experience supporting equipment qualification, process validation, and compliance-driven operational strategies within regulated environments.
• Proven ability to collaborate with clients, external partners, and cross-functional teams while building effective stakeholder relationships.
• Excellent verbal and written communication skills, with the ability to influence stakeholders, think strategically, prioritize competing demands, and execute effectively in dynamic environments.
• Proficient in Microsoft Office applications and capable of working safely and effectively in controlled manufacturing environments, including adherence to Good Documentation Practices (GDP), gowning requirements, and applicable safety protocols.
• Visual acuity requirements, including willingness to undergo visual acuity and color deficiency testing.
• Occasional exposure to moving mechanical parts, biohazardous agents, and electrical Ability to work safely and effectively in controlled manufacturing environments requiring visual acuity, color discrimination, full gowning compliance, and occasional exposure to mechanical equipment, biohazardous materials, and electrical hazards. risk; work in controlled environments with full gowning requirements.

Preferred Skills & Background

• Advanced degree in Science or Chemical/Biological Engineering.
• Familiarity with cell therapy processes, cleanroom facilities, and equipment.
• Experience with autoclaves.
• Experience with cell culturing using T-Flask or G-REX.
• Experience with start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.
• Experience with data aggregation, processing, and analysis software and statistical tools.
• Experience with Data Historian and Distributed Control Systems.

Pay

The anticipated salary range for this position in NJ is $105,000 – $125,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path with annual performance reviews and feedback.
• Diverse and inclusive culture.
• Opportunities for career growth within an organization dedicated to improving lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective from day one.
• Tuition reimbursement program.

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.

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 [e-mail]. 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.