Manufacturing Tech 1 (Service) - 2nd Shift

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

Benefits offered by this job

Medical, dental, vision plans

Life Insurance

Disability Insurance

Retirement Plan

Adoption Assistance

Wellness Programs

Commuter Benefits

Employee Assistance Program

Discount programs

Parental leaves

Job summary

BioMérieux Inc. is seeking a Manufacturing Tech 1 (Service) to operate high-speed, automated manufacturing and packaging equipment for BacT/ALERT bottles in a cGMP environment.

You will support setup, inspection, maintenance, troubleshooting, and cleaning, while ensuring accurate batch documentation and regulatory compliance. Responsibilities include operating HMI/SCADA interfaces, executing manufacturing directions, maintaining organized batch records, and assisting with SOP updates and CAPA

Qualifications

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

Responsibilities

• 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 SOPs.
• Ensure that all batch paperwork is completed accurately, thoroughly, and timely.
• Assist with manufacturing deviation analysis, CAPA actions and other quality concerns.
• Train and certify teammates on production processes and procedures.
• Generate reports and KPI data to identify problems and support decision making.

Skills

Detail orientation

Safety compliance

Documentation

Team training

Education

High School Diploma or GED

BioWorks certificate

LEAN certificate

Tools

HMI/SCADA systems

Job description

Manufacturing Tech 1 (Service)

Title of Direct Supervisor: Manufacturing Production - Management 1

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.

Local 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 and Training

• High School Diploma, GED or equivalent required.
• Certification in a Bioworks Program or equivalent is preferred.
• BioWorks, LEAN or other Continuous Improvement Certificate preferred.
• Will work experience be accepted in lieu of a degree? No

Key Skills, Knowledge and Abilities (KSAs)

• Intellectual Horsepower: Detail orientation to complete tasks without errors and produce high-quality work.
• Getting Organized: Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
• Getting Work Done Through Others: Informing others by sharing clear, timely information to ensure alignment.
• Dealing with Complex Situations: N/A
• Relating Skills: Easily accessible and open to communication
• Acting with Honor and Being Open: Consistently uphold and reflects the core ethical principles and values that bioMerieux promotes
• Acting with Honor and Being Open: Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns.

Working Conditions and Physical Requirements

• Ability to remain in stationary position, often standing, for prolonged periods. Yes
• Ability to ascend/descend stairs, ladders, ramps, and the like. Yes
• Ability to wear PPE correctly most of the day. Yes
• Ability to operate heavy machinery. Yes
• Ability to adjust or move objects up to 50 pounds in all directions. Yes
• Domestic travel required: 0%
• International travel required: 0%
• Total travel: 0%
• 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 is 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

Compensation

The pay for this role in the state of North Carolina is $19.50-$20.25/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.

Benefits

• *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

Equal Opportunity

BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at [phone], by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).