Specialist, Process Engineering (Onsite)

Job Overview Location: Rahway, New Jersey. The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi‑modality (small molecule, biologics, vaccine) drug product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility. The Sterile Process Engineer role at the Specialist level will leverage the individual's leadership, technical, and communication skillsets to drive the success of the clinical manufacturing facility and organization. As the facility approaches the completion of its Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the facility startup and operational readiness activities. Responsibilities Support the pipeline’s most technically complex formulations and process development through process technical transfer, scale‑up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols for sterile clinical drug product operations. Collaborate closely with formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of clinical supplies and the scientific rigor of the processes. Serve as the on‑site engineer based in New Jersey and report to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD). Education Requirements Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related scientific field with a minimum of 3 years of relevant experience. Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related scientific field. Required Experience and Skills Demonstrated enterprise leadership skills. Excellent interpersonal and communication skills, both verbal and written. Experience leading quality investigations and change management. Familiarity with United States and European Union GMP and safety compliance regulations. Ability to convert new drug product attributes and process needs into an executable series of steps and procedures to enable acceptable product manufacture. Ability to prepare Standard Operating Procedures (SOPs) and current GXP documents. Experience with quality systems. Excellent organizational skills. Desire and willingness to learn, contribute and lead. Track record of independent problem‑solving. Preferred Experience and Skills Experience with sterile GMP facility operations. Knowledge of investigational drug regulatory requirements. Understanding of clinical supply chain operations. Expertise in drug product aseptic processing, equipment, and sterile technique. Compensation Salary range: $87,300.00 – $137,400.00. The successful candidate may be eligible for annual bonus and long‑term incentive, if applicable. Benefits We offer a comprehensive package of benefits that may include medical, dental, vision, healthcare and other insurance benefits, retirement benefits including 401(k), paid holidays, vacation, compassionate and sick days. Additional benefit details are available at Work Details Shift: 1st - Day. Travel: approximately 10%. Location: On‑site in Rahway, New Jersey. EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr