Senior Specialist, Engineering (Onsite)

Overview The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey houses a state‑of‑the‑art sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The facility plays a pivotal role in delivering our clinical pipeline worldwide, spanning sterile small molecules, biologics, vaccines, and antibody‑drug conjugates (ADCs). FLEx’s mission is to advance our pipeline with speed, agility, and rigor by enabling robust formulation and process development, delivering compliant, high‑quality clinical supplies, and cultivating talent through a growth mindset. Position Summary The FLEx organization seeks a highly motivated Senior Specialist, Technical Operations Engineer to report to the Technical Operations Engineering Lead. The role supports routine operations through timely troubleshooting and resolution of production equipment issues, establishes new processes, and implements continuous‑improvement projects aimed at reducing cycle time, errors, and costs. Collaboration with Production, New Product Introduction, Facilities, Equipment, Automation, and Quality teams is essential for compliant, right‑first‑time execution and timely delivery of business goals. The position is on‑site in Rahway, NJ, supporting first‑shift operations, with occasional second‑shift and weekend coverage as needed. Education BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related engineering field with a minimum of 5 years of relevant experience. Required Experience and Skills Subject‑matter expertise in sterile processing equipment such as automated filling lines, lyophilizers, autoclaves, part washers, and isolators. Knowledge of automation systems (PLC, DCS, MES). Knowledge of drug‑product aseptic processing techniques. Experience leading and supporting quality deviation investigations and change management. Familiarity with U.S. and EU GMP and safety compliance regulations. Ability to prepare SOPs and current GXP documents. Strong technical aptitude and critical‑thinking skills for effective troubleshooting. Project‑management experience leading cross‑functional initiatives through planning, execution, and risk management. Proficiency in training others and applying best practices to improve processes. Experience with common drug‑product unit operations such as mixing, filtration, and temperature control. Lean Six Sigma Green Belt certification. Effective interpersonal and communication skills, both verbal and written. Excellent organizational skills for multitasking. Willingness to learn, contribute, and lead. Track record of independent problem‑solving. Preferred Experience and Skills Technical mentorship experience with engineers and cross‑functional team members. Experience with commissioning, qualification, and validation of equipment. Understanding of ISA88 and ISA95 principles. Knowledge of investigational drug regulatory requirements. Understanding of clinical supply chain operations. Lean Six Sigma Black Belt certification. EEO Statement We are 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Salary and Benefits Salary range: $117,000.00 – $184,200.00 (adjusted based on education, qualifications, certifications, experience, location, and business needs). Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, insurance, a 401(k) retirement plan, paid holidays, vacation, and compassionate and sick days. Full benefits details are available at #J-18808-Ljbffr Merck