Lead Tech, Operations

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 1000 people.

The Durham site is supporting the expansion of HPV 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 licensure and ramp up to full production.

Durhams 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 Purification production. Position will be a 12 hr 2-2-3 shift schedule either on straight day or night shift (7:00 AM - 7:30 PM; 7:00 PM - 7:30 AM).

Responsibilities may include but are not limited to;

• 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 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 12.5 hour shifts (7:00 AM 7:30 PM or 7:00 PM 7:30 AM)

• Must be willing to work a rotating 2-2-3 schedule (2 days on 2 days off 3 days on) which will 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: None

#MSJR VETJOBS #EBRG TechnicianDurham

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.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

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

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 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 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.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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: