Manufacturing Service Tech 1 - 2nd Shift

bioMerieux; Durham (NC); On-site; USD 27,000 - 28,000; Full time

Benefits offered by this job

Medical, dental and vision plans

Life and AD&D insurance

Disability insurance

Retirement plan with employer match

Job summary

bioMérieux is seeking a Manufacturing Technician in North Carolina to operate high-speed, highly automated equipment for BacT/ALERT production. You will perform setup, inspection, maintenance and cleaning, ensuring accurate batch documentation and adherence to cGMP and SOPs.

The role includes assisting in deviation analysis, CAPA actions and training teammates. Candidates should have a mechanical background and familiarity with OSHA/GMP expectations, with long shifts and over-time as required.

Qualifications

• Regulated production/operations experience preferred.
• Experience operating high-speed automated production equipment preferred.
• Knowledge of OSHA regulations and GMP preferred.
• Mechanical background preferred.

Responsibilities

• Operate high speed manufacturing equipment using HMI/SCADA interfaces.
• Complete production batches and related documentation per SOPs.
• Perform setup, inspection, maintenance, troubleshooting and cleaning of equipment.
• Assist with deviation analysis and CAPA actions.
• Train teammates and generate KPI reports for decision making.
• Validate manufacturing/packaging equipment processes as needed.

Skills

Equipment operation

Troubleshooting

Documentation

Quality compliance

Time management

Education

High School Diploma

BioWorks Certification

LEAN Certification

Tools

HMI/SCADA interfaces

SOP compliance

CAPA processes

Job description

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.
• 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%
• 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.

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.