Senior Deviation Management Engineering Specialist
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.
We are seeking a Growth and Improvement minded individual to lead a Senior Deviation Management Engineering Specialist that can help drive our Strategic Operating Priorities.
Invent | 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
Summary, Focus and Purpose
As part of our Manufacturing Division, Polysaccharide Vaccines Technical Operations at West Point we are searching for a highly motivated leader to partner with the Operations, Quality Operations, and Regulatory groups by leading a deviation management team to meet targeted supply and compliance initiatives.
This position will require development of technical expertise of corresponding IPT operations and mentorship/development of more junior members of the deviation management team. Polysaccharide Vaccines includes fermentation processing, vaccine purification, media preparation, bulk formulation, sterile filtration, and manufacture of conjugate vaccine processes.
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Leads a deviation management team of up to five investigators and provides mentorship/development of more junior team members and contractors
Conducts more complex investigations and drives to appropriate root causes and corrective actions
Collaborates with IPT Operations, Technical Operations, and Quality leadership to identify deviation trends and establish continuous improvement opportunities to reduce potential deviations
Coordinates and prioritizes deviations based on investigator, batch ROT, and supply
Reviews deviations with regulatory agencies and provides health authority reporting
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
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
Approval of technical documentation including investigations, protocols, reports, etc.
Bachelor degree in Chemical Engineering or Biological Science or other appropriate science or engineering field
Experience | Skills | Knowledge
Three years relevant work experience, including direct support of development or manufacturing of biologics/sterile products
Demonstrated leadership and ability to drive results
Principled verbal and written communications, collaboration skills and ability to drive accountability
Strong problem-solving skillset
Participation in regulatory inspections
Experience authoring investigations
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 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.
Residents of Colorado
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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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Residents of Colorado:
Click here to request this role’s pay range.
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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:Hybrid
Shift:1st - Day
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