Senior Technician Operations

Merck & Co. • Durham, NC

318d • Onsite

About The Position

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. 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 through licensure and ramp up to full production. This position will support all Operations areas, including Purification. Off-shift coverage will be required based on business unit needs and specific assignments.

Requirements

• High School Diploma/GED or higher
• Minimum three-year relevant work experience in GMP environment
• Demonstrated written and verbal communication 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

Nice To Haves

• 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

Responsibilities

• Support operations production 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 troubleshoot, Subject Matter Expert in automated systems (SAP, MES, DeltaV).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED