Process Engineer MS&T

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

• ◆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

• ✓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.