Manufacturing Technical Engineering Specialist

Job DescriptionOur Engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. We are seeking a Growth and Improvement minded Manufacturing Technical Engineering Specialist that can help drive our Strategic Operating vent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic LandscapeDiverse Talent | We are dedicated to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the worldValues and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for UsStrategic SummaryThe West Point, Pennsylvania campus is our company''s largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all our company''s vaccine products and is growing to meet the vaccine demands of the future.The Vaccine Filling Facility Project team is seeking a highly motivated individual to fill an open position to assist in the start-up of a new facility at the West Point site. Facility start-up will include design, commissioning, equipment qualification and live virus vaccine drug product process qualification in support of facility licensure.The Manufacturing Technical Engineering Specialist is accountable for technical support for vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture. In this role, the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Operations, Quality, Automation, and others. Key ResponsibilitiesWork independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | InclusionSupport successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facilityPartner with cross functional team to develop process/procedures and complete successful qualification of equipment/processProvide technical expertise for unit operation for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, qualificationAuthor and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validationDevelop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filingsSupport process improvement projects, complex manufacturing investigations and digital/data integrity initiatives for the projectProvide technical support to manufacturing for complex problems and issuesDevelop and assure consistent application of standardized work, engineering, and process toolsExamine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best Identifyand resolve the root causeSupport regulatory submission preparation and inspections for the facilityEducationB.S. in an Engineering or Science Related field with two years of experience in Good Manufacturing Practices (GMP) manufacturing and/or technical support of GMP manufacturing operations ORM.S. in an Engineering or Science Related field with one year of experience in Good Manufacturing Practices (GMP) manufacturing and/or technical support of GMP manufacturing operationsRequiredDemonstrated strong performance record and have excellent project management skillsPrincipled verbal and written communicationsPreferred Experience in vaccine or sterile manufacturing facilitiesValidation experienceExperience leading projects and cross-functional teamsRegulatory inspection presentation experience with external regulatory authority representativesStrong Knowledgeof process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies/certificationOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that''s devoted to delivering a high-quality, reliable supply to customers and patients on time, every timeWho we are ... We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world''s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for ... Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers'' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA Supplement OFCCP EEO SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another''s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Residents of Colorado:Click here to request this role''s pay range. 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: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not SpecifiedShift:1st - DayValid Driving License:NoHazardous Material(s):Number of Openings: 2

Created: 2026-03-07