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.
West Point Technical Operations is seeking a highly motivated individual to provide engineering technical support for a vaccine manufacturing facility. The primary focus of the role is deviation management. This role includes investigation of process deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). The role may also includes process improvements, batch data analysis, batch record management, and support for regulatory inspections. Specific assignments may be focused in one operational area or span multiple areas. Limited additional shift or weekend coverage may be required based on specific assignments.
The individual in this position will be responsible for the following:
Performing investigations for process deviations aimed to prevent recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required.
Managing the customer complaint work-in-progress at tier meetings to evaluate complaints, facilitate the discussions to align with technology and quality approvers / representatives.
Evaluate potential deviations, facilitate the discussions to align with technology and quality approvers / representatives on deviation classification and impact assessment
Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.
Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times.
Supporting team and IPT safety, environmental, and compliance objectives.
Managing investigation timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
Actively using and championing the use of Lean Six Sigma (LSS) and our Company Production System tools, both in problem solving and day-to-day operational activities.
Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
Education Minimum Requirement:
B.S. or M.S Degree in Engineering or other equivalent technical field.
Required Experience and Skills:
Minimum 3 years working experience in engineering discipline or minimum one year working experience in GMP manufacturing / technical support of GMP manufacturing operations
Highly developed communication, leadership and teamwork skills.
Ability to manage projects/work to schedule/deadlines.
Preferred Experience and Skills:
Deviation Management investigator
Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
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 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 APPLICANTS
In 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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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.
Travel Requirements:No Travel Required
Flexible Work Arrangements:
Shift:1st - Day
Valid Driving License: