Job Description

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.

The Durham site is supporting the expansion of vaccine manufacturing to help eradicate HPV-related cancers. Members of the Operations team in this new and exciting facility will have the unique opportunity to experience the design process, licensure, and ramp up to full production.

Durham's Lead Technician, Operations 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 support either Purification production. Position will be night shift 12hrs, 2-2-3. Off-shift coverage will be required based on business unit needs and specific assignments.

Responsibilities may include but are not limited to;

• Support operations production 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

Required Experience and Skills:

• Minimum four-year (4) 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, including evenings(7pm - 7am)

• 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 (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

• Extensive Anion chromatography and large scale column packing experience

• Manufacturing Buffers (small and large scale) with pH and Conductivity adjustments

• Proficient with ultrafiltration / diafiltration (UFDF) using TFF skids

• Sterile filtration into final bulk

• Experience with CIP/SIP of tanks and associated piping

Travel: Up to 0% of the time

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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, Monday - 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".

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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.

Employee Status:

Relocation:

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Flexible Work Arrangements:

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Requisition ID:R332641