Manufacturing Service Tech 1 - Night Shift

bioMérieux • Durham, NC

75d • $20 - $20

About The Position

The Manufacturing Technician operates high-speed equipment used to produce and package BacT/ALERT bottles in a cGMP-compliant manner. The role supports equipment setup, inspection, preventive maintenance, troubleshooting, and cleaning across manufacturing and packaging processes. The technician completes production batches and related documentation, including AQL inspections, rework, and material reconciliation.

This is described as a third-shift role, Monday through Friday from 11:00 p.m. to 7:30 a.m. The posting also states that the job requires 12-hour shifts, including weekends, and may include overnight work. Extended or overtime hours may be required to support production operations.

The position works in production areas with high-speed and automated equipment, mechanical and electrical hazards, and possible exposure to chemicals, antibiotics, hazardous materials, and strong odors. Work is performed in required PPE and cGMP attire. The role reports to Manufacturing Production - Management 1 and has no supervisory responsibilities.

Requirements

• High school diploma, GED, or equivalent.
• Relevant experience in a regulated production or operations environment, or equivalent military experience, is preferred.
• High-speed, highly automated production equipment operation proficiency is preferred.
• Knowledge of and experience following OSHA regulations, including LOTO and electrical safety, is preferred.
• Knowledge of FDA and/or GMP regulations is preferred.
• Mechanical background is preferred.
• Detail orientation, time management, clear and timely communication, accessibility, ethical conduct, and attentive listening.
• Ability to stand for prolonged periods, climb stairs/ladders/ramps, wear PPE correctly for most of the day, and operate heavy machinery.
• Ability to move objects up to 50 pounds in all directions and push or pull objects up to 150 pounds.
• Ability to work extended and/or overtime hours as required.
• Ability to work shifts that may include weekends and overnight hours.
• Work experience is not accepted in lieu of a degree.

Nice To Haves

• Certification in a BioWorks Program or equivalent.
• BioWorks, LEAN, or other Continuous Improvement Certificate.
• Relevant experience in a regulated production/operations environment or equivalent military experience.
• Demonstrated proficiency operating high-speed, highly automated production equipment.
• Knowledge of OSHA regulations, including LOTO and electrical safety.
• Knowledge of FDA and/or GMP regulations.
• Mechanical background.

Responsibilities

• Operate high-speed manufacturing equipment, including highly automated equipment using HMI/SCADA interfaces.
• Execute production activities according to approved Manufacturing Directions and applicable SOPs.
• Complete batch paperwork accurately, thoroughly, and on time.
• Perform and document processes in compliance with company and regulatory requirements.
• Assist with setup, inspection, preventive maintenance, troubleshooting, and cleaning of manufacturing and packaging equipment.
• Perform AQL inspections, rework, and material reconciliation associated with production batches.
• Assist with review and revision of Manufacturing Directions and SOPs.
• Assist with manufacturing deviation analysis, CAPA actions, and equipment-related quality concerns.
• Maintain clean, tidy, and organized work areas in compliance with cGMP requirements.
• Operate cleaning equipment and record data manually or through designated software applications.
• Perform self-audits of rooms and processes.
• Train and certify teammates on production processes and procedures.
• Generate reports, charts, and KPIs; interpret data to identify problems and support decision-making.
• Assist with validation protocols for manufacturing and packaging equipment and procedures, including scheduled or required revalidation.
• Perform computer applications and other assigned duties.
• Perform work in compliance with company quality procedures and standards.

Benefits

• Medical, prescription, dental, and vision plans with nationwide coverage and telemedicine options.
• Company-provided life and accidental death insurance.
• Short- and long-term disability insurance.
• Retirement plan with employer contribution and employer match.
• Adoption assistance.
• Wellness programs.
• Employee assistance program.
• Commuter benefits.
• Voluntary benefit offerings.
• Discount programs.
• Parental leaves.
• Variable annual bonus based on company, team, and individual performance.

What This Job Offers

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