Specialist, Process Engineering (Onsite)

Job Description 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 in Rahway, New Jersey. The Sterile Process Engineer role at the Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization. As the facility is nearing 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. Once the facility is operational, this role will support the pipeline’s most technically complex formulations and process development through process tech transfer, scale‑up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. The individual will collaborate closely with formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of the Company’s pipeline. Responsibilities Lead and contribute to the launch and regulatory certification of the facility startup and operational readiness activities. Support the pipeline’s most technically complex formulations and process development through process tech transfer, scale‑up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols. Collaborate closely with formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure quality, scientific rigor, and flexibility of the pipeline. Qualifications Education Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience. Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field. Required Experience and Skills Excellent enterprise leadership skill demonstration. Excellent interpersonal and communication skills, both verbal and written. Experience in 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 to an executable series of steps and procedures to enable acceptable product manufacture. Ability to prepare Standard Operating Procedures (SOP) 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. Salary Salary range: $87,300.00 - $137,400.00. Benefits We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits, paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights and EEOC GINA Supplement. We are proud to embrace the value of bringing together talented and committed people with diverse experiences, perspectives, skills, and backgrounds. We encourage respectful challenge and collective problem solving. Location New Jersey (on-site). The role is part of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD). Reports to the Sterile Process Engineering Lead. Eligibility US and Puerto Rico Residents only. For accommodation during the application or hiring process, please contact us. #J-18808-Ljbffr MSD