Senior Fermentation Technician, Durham NC

Job Description

Senior Technician, Operations

Job Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.

Durham's Senior Technician, Operations will be an energetic leader with strong interpersonal, communication, and collaboration skills responsible for supporting the manufacturing process. Individual will possess the ability to lead a small team, train others and contribute to process improvements.

This position will support the vaccine drug substance site readiness, commissioning and qualification through licensure and ramp up to full production. This position will support all Operations areas, including Purification and Fermentation. Off-shift and weekend coverage will be required based on business unit needs and specific assignments.

Responsibilities may include but are not limited to;

• Support operations production through start-up and commissioning and qualification through licensure and ramp up.
• Participate in document design activities working alongside operations team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
• Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones.
• Working in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for the production.
• Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and traceability of product.
• Maintains, inventories, and transports all required equipment, materials, supplies and products. Ensures shipment criteria and timely availability and delivery.
• Performs general maintenance and assists or ability in troubleshooting of equipment independently
• Performs sampling/in-process testing supporting the manufacturing and validation process for current process
• Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.
• Performs housekeeping in all work areas. Executes facility decontamination according to procedures. Maintains, cleans and prepares equipment used in production.
• Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.
• Serves on safety, quality and other committees as required.
• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.
• Attends and actively participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
• Self-motivated to maintain own training status and ability to train others.
• Works independently, Trains others, and ability to trouble shoot, Subject Matter Expert in automated systems (SAP, MES, DeltaV).

Education Minimum Requirement:

• High School Diploma/GED or higher

Required Experience and Skills:

• Minimum three-year relevant work experience in GMP environment
• Demonstrated written and verbal communications skills
• Must be willing and able to lift 50 lbs and work on elevated platforms
• Must be willing to work 12-hour shifts 7am-7pm
• Must be willing to work a rotating 2-2-3 schedule (2 days on, 2 days off, 3 days on) which may include weekends

Preferred Experience and Skills:

• Demonstrated 1-2 years of leadership experience
• Minimum Associates Degree in science or related field
• Applicable mechanical and project management experience
• Proficiency with automated systems (MES, SAP, DeltaV)
• Experience training others and/or leading hands-on or instructor-led training
• Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements
• Demonstrated ability to work both independently and as a part of a team

Travel: 0%

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. #VETJOBS #EBRG MSJR TechnicianDurham.

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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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:
No Travel Required

Flexible Work Arrangements:
On-Site

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
None

Requisition ID:R254177