Sr. Specialist, Engineering (Onsite)

Job Description The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational startup phase. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). Position Overview We are seeking a Sterile Operations Senior Engineer to serve as a key Senior Specialist in the FLEx Sterile Expansion Project, which is under construction activities. This expansion project aims to more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, and a sterile supply suite, along with various supporting infrastructure and utilities. As construction of the expansion project continues, the selected candidate will lead operational readiness workstreams within the FLEx Sterile Expansion Project. They will leverage their relevant experience to contribute to equipment and facility design, system commissioning and qualification, and other critical activities necessary for facility startup. This role presents an exciting opportunity to collaborate with automation, digital and IT teams, equipment vendors, operations, global engineering and other stakeholders. Together, you will drive the design aspects, conduct risk assessments, engage in strategic planning, and ensure the successful execution of the project C&Q and startup phases of a new aseptic drug product filling facility. When operations commence, this individual will partner closely with the Formulators, Engineers, Quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of our Company's sterile pipeline. Key Responsibilities Collaborate closely with stakeholders to gain insights into equipment and facility design, maintenance, troubleshooting, operational excellence, financial and capital management, team building, process sciences, technical writing, and networking Operate state-of-the-art aseptic drug product formulation, filling, and lyophilization equipment throughout the manufacturing cycle. Perform aseptic manipulations within Grade A barrier isolation systems. Manage individual project assignments and aid in facility and process equipment innovation. Perform manual and/or automated operations, general maintenance, troubleshooting and support functions Participate in operational readiness planning and documentation by developing and maintaining SOPs, work instructions, batch records, training curricula, process flows, job aids, and visual management tools to support compliant execution and go-live readiness. Identify and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel Demonstrate safe work habits and maintain a safe work environment. Comprehend and comply with all safety and company policies and procedures. Attend training classes, workshops, meetings, etc., as needed to improve job skills and product-related procedures. Lead the planning, execution, and value realization of digital tools developed to drive rapid insights on the production process for troubleshooting and predictive analytics Lead training, readiness assessments, and continuous improvement through onboarding programs, dry runs, simulations, issue tracking, and escalation planning to ensure personnel and processes are fully prepared before GMP Manufacturing. Education Minimum: Bachelor's degree in Engineering, Science, Operations Management or equivalent with a minimum of 5 years of relevant experience. Master’s degree with a minimum of 3 years of relevant experience Qualifications: Manufacturing and GMP expertise: Experience in sterile drug product manufacturing, aseptic technique, quality systems, GMP/clinical supply operations, and investigational drug requirements. Technical and equipment skills: Ability to operate, set up, adjust, and troubleshoot complex equipment, including robotics, automated systems, and packaging/assembling machinery. Documentation and compliance: Strong documentation skills, with experience preparing SOPs and GxP documents, supporting investigations, change management, and Commissioning/Qualification/Validation. Problem-solving and teamwork: Strong attention to detail, effective communication, and the ability to collaborate in a manufacturing environment. Data and digital tools: Proficiency with data analysis and organization tools such as MS Access, Excel, Minitab, Power BI, and R Shiny. Startup and continuous improvement: Experience in new GMP facility startup and knowledge of Lean principles. Working conditions: This position may have varying hours based on the needs of the business Flexibility working overtime is a requirement in manufacturing Travel maybe necessary during facility construction/startup Travel: Up to 10% of the time. #eligibleforERP #PSCS FLEx2026 Sterile2026 Required Skills: Analytical Testing, Detail-Oriented, Equipment Qualification, Good Manufacturing Practices (GMP), Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving Preferred Skills: Automation, Continuous Improvement, Process Engineering Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. 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 EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 09/23/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R416340