Senior Specialist, Engineering

Job DescriptionOur Engineers support internal and external manufacturing operations 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 Senior Manufacturing Engineer Specialist that can help drive our Strategic Operating PrioritiesInvent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

Execute | 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 Landscape

Diverse Talent | We are committed 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 world

Values 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 Us

Strategic SummaryReporting to the Associate Director, the Senior Specialist, Engineering is responsible for providing technical support to the Bottle/Blister/Vaccine Integrated Production Teams in determining the best method for providing optimum performance in manning, equipment, systems, documentation, and asset utilization and is also responsible for process performance support and troubleshooting for products manufactured at our Wilson facility. The successful candidate will work closely with Packaging Technology for the transfer of new products and processes from our Research & Development Division or our Manufacturing Division sites to our Wilson facility.The basic function of this position is to, independently or as part of a project team, plan, design and implement varied technical projects and studies requiring knowledge of engineering and/or pharmaceutical sciences. This role requires expertise and full application of sound scientific principles, theories, concepts, techniques, and project management skills, as well as working knowledge of our Company methods, standards, procedures, and practices. The Senior Manufacturing Engineer Specialist is expected to collect and interpret information, to develop solutions and to make decisions with high liability to projects of varying scopes. Expertise in qualification and process validation practices for complex systems is essential to success in this role. Very minimal supervision, guidance, and direction are employed by the Associate Director, however, periodic checks and reports are required to review soundness of technical judgement and the status/schedule of the effort and will also provide leadership and training to others.Key ResponsibilitiesAccountable for the scale-up and technology transfer of pilot processes to production scale for our Manufacturing site in Wilson which includes support for equipment design, equipment qualification, process demonstration, and process validation

Technical assistance to packaging operations in the resolution of processing problems for in-line products

Written scientific justification for proposed changes by conducting literature search, designing and executing experiments, analytically reviewing current and past data, and demonstrating the impact of process changes on product quality, production efficiency, or productivity

Technical assistance for quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observation, and environmental process issues

Drives accuracy of Packaging Process Descriptions which requires a thorough knowledge of the packaging operations, the hazards involved, and the in-process controls necessary to obtain reproducible results

Responsible for completing all process engineering/process development activities with the highest regard for all of our Company Divisional policies and Wilson site procedures for safety, quality, and regulatory compliance

Review literature pertaining to pharmaceutical packaging in order to introduce new profitable/productivity ideas into the packaging operation

Technical support in critically evaluating quality standard specifications and methods for raw materials and intermediate and final products

EducationBachelor degree in Engineering, Industry Technology

RequiredWork independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

Five years' relevant industrial experience

Experience working in a GMP Pharmaceutical Environment

Demonstrated leadership and teamwork skills

Excellent analytical ability

Proven communication skills

Work under limited supervision

Our 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 time.Who 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 HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA Supplement​OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay 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 (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.Search Firm Representatives Please Read CarefullyMerck & 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:Travel Requirements:Flexible Work Arrangements:Shift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R193529