Senior Process Engineer - Non-Sterile Operations (On-site)

The Non-Sterile (Oral Solid Dosage) team at the FLEx Center in Rahway is looking for a Sr. Specialist - Process Engineer to lead clinical supply manufacturing with scientific rigor in processes, to ultimately enable flexibility and speed in our company's pipeline.

Responsibilities

• Lead on-the-floor batch manufacturing in a pilot plant while prioritizing and ensuring safety and quality of clinical supplies.
• Draft and execute GxP documentation including batch records, equipment qualification and cleaning, change records and deviations.
• Identify and resolve technical and operational problems, collaborating with peers to resolve problems that cross into interrelated units.
• Facilitate and support early process development by assisting in lab activities, and supporting knowledge transfer for scaling at pilot plant scale with relevant partners, via technical reports and presentations.
• Propose new, innovative approaches for enhanced process and product understanding.
• Support process development activities using Design of Experiments for new chemical entities or life cycle management opportunities.
• Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.
• Foster a culture of collaboration, learning and innovation.
• Support in setting specific and measurable short- and long-term goals.

Required Experience and Skills

• Proven ability to identify and develop innovative ideas.
• Strong problem-solving skills and a direct involvement approach to problem solving.
• Ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and identify root cause.
• Demonstrated ability to independently design and execute complex experiments and analyze data.
• Familiarity with GMP and safety compliance regulations.
• Ability to work effectively with team members of diverse skill sets and backgrounds.
• Strong interpersonal and communication skills, both verbal and written.

Education Minimum Requirements

• Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience.
• Master's degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with 3 years of relevant experience.
• PhD in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected graduation no later than December 2026).

Preferred Experience and Skills

• Experience executing GxP manufacturing in a pilot plant or a commercial manufacturing environment.
• Experience with small molecule drug product manufacturing technologies, including blending, granulation, compression, encapsulation, film coating, spray drying, and hot-melt extrusion.
• Experience with process modeling, simulation, and automation integration in the pharmaceutical and/or industrial manufacturing sector.
• Experience or interest in supporting electronic batch records and MES systems.
• Experience in leading and supporting quality investigations and change management.
• Experience with Commissioning, Qualification and Validation.
• Knowledge of investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through the development, optimization and execution of novel production technologies.
• Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.

Schedule

This role supports operational coverage across multiple shifts. Candidates must be willing and able to float between 1st and 2nd shift. Work schedules for this role will vary based on the needs and timing of assigned campaigns. Hours: 1st shift - 7:30am - 4pm; 2nd shift - 3pm - 11:30pm.