Senior Process Engineer - Non-Sterile Operations (On-site)

Job description

Job Description The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our Company’s research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials. The Non-Sterile (Oral Solid Dosage) team at the FLEx Center in Rahway is looking for a Sr. Specialist - Process Engineer to lead clinical supply manufacturing with scientific rigor in processes, to ultimately enable flexibility and speed in our company's pipeline. This person will: Lead on-the-floor batch manufacturing in a pilot plant while prioritizing and ensuring safety and quality of clinical supplies. Draft and execute GxP documentation including, but not limited to, batch records, equipment qualification and cleaning, change records and deviations. Identify and resolve technical and operational problems, collaborating with peers to resolve problems that cross into interrelated units . Facilitate and support early process development by assisting in lab activities, and supporting knowledge transfer for scaling at pilot plant scale with relevant partners, via technical reports and presentations. Propose new, innovative approaches for enhanced process and product understanding. Support process development activities using Design of Experiments for new chemical entities or life cycle management opportunities. Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives. Foster a culture of collaboration, learning and innovation. Support in setting specific and measurable short- and long-term goals. Required Experience and Skills: Proven ability to identify and develop innovative ideas. Strong problem-solving skills and a direct involvement approach to problem solving. The candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and identify root cause. Demonstrated ability to independently design and execute complex experiments and analyze data. Familiarity with GMP and safety compliance regulations. Ability to work effectively with team members of diverse skill sets and backgrounds. Strong interpersonal and communication skills, both verbal and written. Education Minimum Requirements: Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience, or a Master’s degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with 3 years of relevant experience, or a PhD in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected graduation no later than December 2026). Preferred Experience and Skills: Experience executing GxP manufacturing in a pilot plant or a commercial manufacturing environment. Experience with small molecule drug product manufacturing technologies, including: blending, granulation, compression, encapsulation, film coating, spray drying, and hot-melt extrusion. Experience with process modeling, simulation, and automation integration in the pharmaceutical and/or industrial manufacturing sector. Experience or interest in supporting electronic batch records and MES systems. Experience in leading and supporting quality investigations and change management. Experience with Commissioning, Qualification and Validation. Knowledge of investigational drug regulatory requirements. Understanding of Clinical Supply Chain Operations. Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through the development, optimization and execution of novel production technologies. Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies. Schedule: This role supports operational coverage across multiple shifts. Candidates must be willing and able to float between 1st and 2nd shift. Work schedules for this role will vary based on the needs and timing of assigned campaigns. Hours: 1st shift - 7:30am - 4pm 2nd shift - 3pm - 11:30pm EligbleforERP Required Skills: Chemical Engineering, Deviation Management, Drug Product Manufacturing, Equipment Qualification, Good Manufacturing Practices (GMP), GxP Regulations, Manufacturing Process Engineering, Oral Solid Dosage, Pharmaceutical Industry, Process Design, Process Optimization, Root Cause Analysis (RCA) Preferred Skills: 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 primary location for this posting is: USA - New Jersey - Rahway Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $117,000.00 - $184,200.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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. Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensati