Associate Director, Process Engineering

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The FLEx Sterile Process Engineer at the Associate Director level is a technical subject matter expert responsible for process development, equipment optimization, and capability enhancement within the sterile development facility. This role involves collaboration with various teams to develop sterile drug product formulations and provide mentorship to process engineering colleagues. The engineer will drive continuous improvement initiatives and uphold safety and compliance standards in the FLEx Center.

Responsibilities

• Serve as a technical expert and mentor to a team of process engineers.
• Provide troubleshooting support on the shop floor.
• Drive internal capability development by evaluating and deploying new drug product technologies.
• Collaborate effectively within and across functional areas.
• Maintain awareness of relevant new and current technologies and share this knowledge with others.
• Participate in external and internal audits, tours, and inspections.
• Execute investigations as needed.
• Lead and drive a culture of continuous improvement across the facility.

Requirements

• Ph.D. in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field with a minimum of 4 years of relevant experience, or a B.S. or M.S. in the same fields with a minimum of 7 years of relevant experience.
• Knowledge of sterile drug product processing.
• Experience with GMP manufacturing.
• Effective interpersonal and communication skills, both verbal and written.
• Excellent organizational skills to handle multiple priorities.
• Track record of independent problem-solving.

Nice-to-haves

• Experience with GMP facility operations.
• Experience in leading and supporting quality investigations and change management.
• Experience with quality systems.
• Familiarity with US and EU GMP and Safety compliance regulations.
• Experience with SAP, ERP, or MES systems.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days