Senior Technical Operations Engineer

Job Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in northern Durham, North Carolina. This state-of-the-art facility, whose construction started in 2004, is manufacturing our company's life-saving vaccines. Due to the importance of this facility in our company's Vaccine Manufacturing Supply Chain, the facility has seen rapid growth in production volumes and new employees over the last several years; currently; Durham employs 600+ people.

Our ability to excel relies on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to work with talented and dedicated colleagues while developing and expanding your career.

The Technical Operations team at our Vaccine Facility in Durham, North Carolina, is seeking a Senior Engineer. The Technical Operations team provides technical engineering and manufacturing support for the production of our company's live virus vaccines at Durham. The Senior Engineer will partner with Manufacturing Operations, Quality Operations and Process Automation to support a sterile fill, finish, lyophilization vaccine manufacturing facility in Durham, NC. The Technical Operation's team expansion offers challenging employment and professional growth opportunities for skilled engineers and scientists. The successful applicant for the role will have the opportunity to become part of this exciting team supporting the Durham facility.

The Senior Engineer The Senior Engineer role requires the ability to execute multiple projects and activities across the Integrated Process Team. Strong communication and collaboration skills are essential. The successful candidate will also have robust problem-solving skills and a hands-on approach to problem-solving and equipment validation, with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuous learning is a requirement.

Primary Activities:

• Analyzing complex processing problems through critical analytical thinking
• Provide technical support to the manufacturing shop floor for in-process analytics, controls, and troubleshooting
• Development of sound scientific justification for planned material, process and equipment changes
• Working with the Operations, Automation, and Quality functions to establish the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions and determine product disposition.
• Preparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change requests. Acts as a participant in domestic and international regulatory agency inspections.
• Supporting all quality and safety initiatives.
• Communicating with management about progress of projects and making improvement recommendations on production procedures.
• Strong communication, leadership and teamwork skills.

Education:

• Bachelor's degree in an Engineering or Science related field AND a minimum of five (5) years of experience OR
• Master's degree in an Engineering or Science related field AND a minimum of three (3) years of experience.

Required Experience and skills:

• Problem solving skills
• Technical writing skills
• The ability to work independently and as part of a team.

Preferred Experience and Skills:

• Experience with optimizing and troubleshooting aseptic processing operations such as formulation, filling, lyophilization, or automated inspection processes.
• Familiarity with process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies

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.

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:

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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.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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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:
10%

Flexible Work Arrangements:
On-Site

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R253267