Merck Senior Specialist, Engineering - West Point Technical Operations in West Point, Pennsylvania
Our 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.
The Senior Specialist, Engineering, will be responsible for support of production of live virus vaccines within Building 29. This engineer will be a member of the Technical Services Deviation Management team in the Live Virus Vaccine Manufacturing End-to-End at the West Point site. The primary responsibility of the individual will be investigation initiation and closure associated with vaccine technology/production in support of formulation and final product filling operations. Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/ equipment actions, and other related duties. This position will require development of technical expertise of corresponding IPT operations and mentorship/development of more junior members of the team. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.
Additional responsibilities include the following:
Leads and/or works as a team member on manufacturing investigations and/or process improvement projects.
Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
Assures consistent application of standardized work, engineering and process tools.
Provides technical support to manufacturing shop floor for problems and issues.
Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. Includes approval of technical documentation including investigations, protocols, and reports etc. as required. May be responsible for presenting technical discussions to regulatory agencies during inspections.
Education Minimum Requirements:
- B.S. degree in Engineering or Sciences.
Required Experience and Skills:
Minimum of 2 years relevant work experience, including direct support of development or manufacturing of biologics / sterile products (or M.S. degree with <1 year experience).
Demonstrated leadership and ability to drive results
Strong communication, collaboration skills and ability to drive accountability
Strong problem-solving skillset
Preferred Experience and Skills:
Participation in regulatory inspections
Experience authoring investigations
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Our Company., Inc., Kenilworth, New Jersey, USA in the United States and Canada and Our Company 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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
NOTICE FOR INTERNAL APPLICANTS
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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.
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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R94802
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