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Associate Specialist, Engineering, Deviation Management USA - North Carolina - Durham (Old Oxford)

Job Description

Our Engineers support internal and external manufacturing operations to ensure they remain operational, and 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.

Our company is a global health care leader with a diverse portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

The Associate Deviation Management Specialist - Process Engineer will support business and Manufacturing Operations by researching and authoring deviations within the Deviation Management team as part of the Durham Technical Operations team. The Durham Technical Department is a team of dedicated engineers who strive to understand, monitor, improve and support the transfer of our manufacturing processes. Within these groups, there are opportunities to support day-to-day activities and strategic projects to ensure the Durham Bulk and Formulation/Filling facilities operate Right-First-Time in a cost-effective manner, and to ensure on-going Technical Transfer activities to the site meet the financial and timeline requirements for the vaccine programs. This role requires daily problem solving with other Technical CoE groups, Operations, and Quality. The successful candidate will be expected to be a first responder to requests from the manufacturing areas when support is needed.

The well-qualified candidate must have analytical, problem-solving, and communication skills. In this role, the candidate will provide support for the manufacturing of aseptic products. Furthermore, the candidate will be required to work in a fast-paced environment. Off-shift or weekend coverage may occasionally be required to support the technical team, based on project-specific assignments and/or the vaccine production schedule.

Responsibilities include but are not limited to:

  • Authoring technical documentation
  • Lead troubleshooting and resolution of unplanned events to ensure a reliable supply of Durham manufactured vaccines
  • Accountable for delivering on Durham manufacturing objectives
  • Accountable for providing technical support to Durham current and pipeline vaccine manufacturing
  • Lead technical and business system process improvement projects



Education Minimum Requirement:

  • Bachelor's Degree or higher in Engineering or Sciences



Required Experience and Skills:

  • 1+ years relevant experience.
  • Ability to perform aseptic gowning during the execution of job duties
  • Strong leadership, interpersonal and communication skills (written and oral) are required



Preferred Experience and Skills:

  • Knowledge of Lean Six Sigma practices and methods
  • Knowledge of aseptic processing operations
  • Knowledge of data analysis



Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals 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.

For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We 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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R219822

Associate Specialist, Engineering, Deviation Management USA - North Carolina - Durham (Old Oxford)

Durham, NC
Full Time

Published on 01/25/2023

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