Specialist, 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. This role will have extensive leadership potential as the first representative of our team on second shift. 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. This 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 our Company's pipeline. Responsibilities Lead and contribute to the launch and regulatory certification of the facility startup and operational readiness. Support the pipeline’s most technically complex formulations and process development through process tech transfer and scale‑up activities. Conduct quality investigations and manage change initiatives. Author GMP standard operating procedures and protocols for sterile clinical drug product operations. Collaborate with formulation scientists, engineers, operations staff, quality representatives, and team members to ensure product quality and process rigor. Qualifications Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field with a minimum of 3 years relevant experience. Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field. 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 Qualifications Experience with sterile GMP facility operations. Knowledge of investigational drug regulatory requirements. Understanding of clinical supply chain operations. Benefits Salary range: $87,300.00 – $137,400.00. Users may be eligible for an annual bonus and long‑term incentive, if applicable. A comprehensive benefits package includes medical, dental, vision, other insurance benefits for employees and families, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. More information is available at . EEO Statement We are an Equal Employment Opportunity Employer 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. #J-18808-Ljbffr Merck & Co.