Lead Sterile Supply Technician, Operations (Days)

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

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.

This position is in direct support of our Sterile Supply manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities of: Component Assembly, GMP Autoclaves, Dry Heat Ovens, Parts Washers, and area cleaning. As a Lead Technician in Operations, you will be a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.

This position will also support of our Intermediate Adjuvant manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities of: Buffer Preparation, Solutions Preparation, Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning. As a Lead Technician in Operations, you will be a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.

Responsibilities may include but are not limited to:

• Support operations production through start-up and commissioning and qualification through licensure and ramp up.

• 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.

• Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job aides, and learning documents.

• Performs general maintenance and assists or ability in troubleshooting of equipment independently.

• 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.

• Performs sampling/in-process testing supporting the manufacturing and validation process for current process as well as developmental work for new products/processes as required independently.

• 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.

• Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones.

• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.

• Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and SMEs.

• Analyzing and implementing initiatives, training programs, and systems that will help to increase overall success within the department.

• Participate in training for new hire training programs.

Education Minimum Requirement:

• High School Diploma/GED or higher

Minimum Required Experience and Skills:

• Minimum 3 years 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:

• day position hours will be 7am-7pm.

• Must be willing to work a 2-2-3 schedule (2 days on, 2 days off, 3 days on) which includes every other weekend.

Preferred Experience and Skills (General):

• Demonstrated 2-4 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

• Demonstrated knowledge of Lean Six Sigma/MPS principles

• 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

• Strong collaboration, communication, and leadership skills

• Experience in bulk vaccine Intermediate / product adjuvant experience.

• Experience with GMP Washers, Autoclaves and Dry Heat Ovens / Sterile Component Building experience.

Travel: Up to 25% of the time

NOTICEFORINTERNALAPPLICANTS

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. MSJR VETJOBS TechnicianDurham #EBRG

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, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R280103