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Merck KGaA Darmstadt Germany - Durham, NC
posted about 2 months ago
About the position
The Vaccine Manufacturing Operations Technician position is a full-time role focused on supporting the vaccine manufacturing process through hands-on processing activities. The technician will work in a team environment to execute aseptic processing requirements, adhere to Good Manufacturing Practices, and contribute to the overall production goals of the facility. This role is essential for ensuring the quality and efficiency of vaccine production as the facility transitions into commercial production.
Responsibilities
- Collaborate with operations and support personnel to perform manual and automated processing of vaccine manufacturing equipment.
- Execute all documentation and clerical functions necessary for proper accountability and traceability of product.
- Maintain, inventory, and transport all required processing equipment, materials, supplies, and products needed to support manufacturing.
- Operate various computer-controlled process support/process equipment (e.g., washers and autoclaves).
- Assist in troubleshooting of equipment.
- Perform housekeeping in all work areas and execute facility sanitization and decontamination according to approved procedures.
- Complete in-process testing and inspections supporting the vaccine manufacturing, validation, and development processes as required.
- Identify and address compliance, environmental, safety, and process deviations and escalate to appropriate personnel.
- Schedule and perform environmental monitoring during processing and record results in the computerized database system.
- Attend and actively participate in safety & housekeeping, walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety, or environmental training/initiatives as required.
- Serve on safety, quality, and other committees as required.
Requirements
- High School Diploma or equivalent is required; Bachelor's degree in Life Science or Engineering preferred, or Associate's degree in Life Science or Engineering with at least 2 years relevant experience.
- Previous experience in pharmaceuticals or related experience in manufacturing is a plus.
- Ability to successfully gown into C/D graded spaces.
- Willingness and ability to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator.
- Demonstrated verbal and written communication skills.
- Basic computer literacy (internet browsers, e-mail, word processing) is required.
- Successful completion of TB titer and Chest X-ray are required.
Nice-to-haves
- Bachelor's degree in Life Science or Engineering.
- Associate's degree in Life Science or Engineering.
- BioWorks Certificate (working in an FDA regulated industry).
- Experience utilizing System Applications and Products in a manufacturing setting.
- Experience in the use of Electronic Batch Records.
- Experience performing Environmental Monitoring and Sampling.
Benefits
- Health insurance coverage
- Dental insurance coverage
- Life insurance coverage
- 401k benefit for retirement savings plan
- Paid holidays
- Paid time off (PTO)
