Lead Technician, Operations - Night Shift
- Durham, NC
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's 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 Lead Technician, Operations will be a leader with strong interpersonal, communication, and collaboration skills. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.
This position will support either Fermentation, Purification, Alum Adjuvant, or Sterile Supply production. Position will start as Monday-Friday during the project phase and transition to shift. 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.
- 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.
- 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.
- 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
- 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:
- 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
- Up to 25% of the time
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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.
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Flexible Work Arrangements:
3rd - Night
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