Lead Tech, Operations (Operational Compliance)

Merck KGaA Darmstadt Germany • Durham, NC

109d • 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. This is a day/night shift position, 12.5 hour (6:00 AM - 6:30 PM; 6:00 PM - 6:30 AM) rotation (2-2-3). The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with expertise working in aseptic production and manufacturing operations. The Lead Technician is a manager developmental role and will serve on the Operations leadership team.

Requirements

• High School Diploma or equivalent is required for this position.
• Qualified in at least 1 manufacturing area.
• Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.
• Must be able to work both independently and within multi-functional teams in a fast-paced environment.
• Experience with pharmaceutical process systems including PAS-X, DeltaV, SAP, RtReports, GLIMS.
• At least four (4) years GMP manufacturing/processing experience or at least two (2) years GMP manufacturing/processing experience with a Bachelor's degree in Life Science or Engineering.
• Must be willing to work 12-hour day/night shift (6:00 AM to 6:30 PM; 6:00 PM to 6:30 AM) on a rotating 2-2-3 schedule.
• Must be able to successfully pass and maintain aseptic gowning qualification.
• Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator.
• Must be willing to be vaccinated/blood tested for titer for products manufactured within the facility if needed.
• Computer literacy (internet browsers, e-mail, spreadsheets, word processing).
• Experience with batch record execution, including good documentation practices.

Nice To Haves

• BioWorks Certificate (working in an FDA regulated industry).
• Environmental Monitoring and Sampling.
• Proficiency in the use of SAP in a manufacturing setting.
• Review of Electronic Batch Record.
• Certified Yellow Belt/Green Belt.

Responsibilities

• Executes operational review and comment resolution of batch records to include binder assembly.
• Maintains gown qualification.
• Maintains qualification within at least 1 suite.
• Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the shop floor.
• Assists with label preparation (e.g., GLIMS, Release) for upcoming production.
• Executes operation sample management of samples handled within Durham.
• Reviews special communications at shift change to include 4-Quad.
• Executes room incursion initiation and approvals.
• Assists Manager in leading a team-based culture through continuous improvement activities.
• Assists Manager with facilitating shift change.
• Performs inventory control and cycle counts.
• Resolves and reports issues with product accountability and SAP system discrepancies.
• Assists team in real-time batch record review and ensures timely closure of shop floor order.
• Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively.
• Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.
• Identifies and addresses compliance, environmental, safety, and process deviations as required and escalates to appropriate personnel.
• Serves as a back-up to the Operations Coach on shift, as required.
• Serves as back-up to the suite O4 or other missing role to support daily processing activities, as required.

What This Job Offers

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