Manufacturing Service Tech 1 - 2nd Shift

BioFire Diagnostics; Durham (NC); On-site; USD 26,000 - 28,000; Full time

Benefits offered by this job

Competitive Total Rewards package

Job summary

BioMérieux is seeking a Manufacturing Service Technician 1 in North Carolina to operate high-speed equipment for BacT/ALERT production. You will perform setup, inspection, preventive maintenance, and cleaning, ensuring batch documentation and adherence to SOPs.

The role involves training teammates, contributing to CAPA actions, and maintaining compliant work environments while supporting production goals. 12-hour shifts, overtime may be required.

Qualifications

• High School Diploma, GED or equivalent.
• Certification in a BioWorks Program or equivalent preferred.
• BioWorks, LEAN or other Continuous Improvement Certificate preferred.
• Knowledge of OSHA regulations (LOTO, electrical safety) preferred.
• FDA or GMP familiarity preferred.

Responsibilities

• Operate high-speed manufacturing equipment using HMI/SCADA interfaces.
• Execute production activities per approved Manufacturing Directions while following SOPs.
• Ensure batch paperwork is accurate, thorough, and timely.
• Perform and document processes in compliance with regulations and QA.
• Review and revise Manufacturing Directions and SOPs as needed.
• Assist with CAPA actions and other quality-related issues.
• Maintain clean, organized work areas in cGMP compliance.
• Generate reports, charts and KPI data for decision making.
• Support validation protocols and revalidation activities as scheduled.

Skills

Detail orientation

Time management

Clear communication

Ethical principles

Active listening

Team collaboration

Documentation

cGMP awareness

Education

High School Diploma or GED

BioWorks Certification or equivalent

LEAN or Continuous Improvement certificate

Job description

Manufacturing Service Technician 1

Position Summary

The Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner.

Responsibilities:

• The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.
• Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks.
• AQL inspections, reworks and Material reconciliation that goes along with the batch.

Primary Duties

• Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces.
• Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs.
• Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner.
• Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations.
• Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
• Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns.
• Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements.
• Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.
• Perform self-audit of rooms and processes.
• Train and certify teammates on production processes and procedures.
• Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making.
• Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state.
• Perform computer applications.
• Perform all work in compliance with company quality procedures and standards.
• Performs other duties as assigned.

Qualifications

Experience

• Relevant experience in a regulated production/operations environment, OR Equivalent military experience preferred.
• Demonstrated proficiency in the operation of high speed, highly automated production equipment preferred.
• Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
• Knowledge of FDA and/or GMP regulations preferred.
• Mechanical background preferred.

Education & Training

• High School Diploma, GED or equivalent.
• Certification in a Bioworks Program or equivalent is preferred.
• BioWorks, LEAN or other Continuous Improvement Certificate preferred.

Key Skills (Knowledge, Skills & Abilities)

• Detail orientation to complete tasks without errors and produce high-quality work.
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Informing others by sharing clear, timely information to ensure alignment.
• Easily accessible and open to communication.
• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns.

Working Conditions & Physical Requirements

Physical Requirements

• Ability to remain in a stationary position, often standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery.
• Ability to adjust or move objects up to 50 pounds in all directions.

Travel Requirements

• Domestic travel required: 0%
• International travel required: 0%
• Total travel: 0%

Additional Working Conditions

• May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches away.
• May be exposed to Chemical Hazards and require the handling of chemicals, antibiotics and/or hazardous materials.
• May be exposed to strong odors incurred during media production or other operations.
• Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.
• Ability to work extended and/or overtime hours as required to support production operations.
• The job requires working 12-hour shifts which will include working on weekends and may include working overnight.
• The job utilizes equipment and processes which include mechanical hazards, electricity hazards, and tripping / falling hazards.
• Must be able to push/pull objects up to 150lbs.

Supervisory Responsibilities

• Direct supervision: 0 (Not applicable)
• Indirect supervision: 0 (Not applicable)

Reports To

Manufacturing Production - Management 1

The pay for this role in the state of North Carolina is $19.25-$20/hr. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

In addition, bioMérieux offers a competitive Total Rewards package that may include:

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves