Formulation Tech 1 - Night Shift (B)

Description

Benefits at bioMerieux:
Low-cost medical, dental, and vision benefits starting day one
11 paid holidays
160 hours of paid time off
Annual bonus
9.5% 401k company contribution with no vesting period
Tuition reimbursement up to $10,000 per calendar year
Onsite cafeteria with a daily food stipend

Position Summary & Responsibilities:

The role will follow a 2-2-3 schedule, night shift from 7pm to 7.30am.

The Formulation Technician is responsible for the processing and formulation of large- and small-scale bulk intermediate liquids, polymers, biologicals, and chemicals used in the reagent manufacturing of BACT/ALERT bottles. This role requires precise execution, as Formulation is responsible for the manufacture of complex reagents that may be used in over ~$500k worth of product per shift. Operations and documentation must be completed in strict compliance with Good Manufacturing Practices (GMP), ensuring Right First Time (RFT) performance to maintain production quality and prevent costly rework.

• Formulation / Manufacturing:
  • Manufacture highly automated large- and small-scale bulk intermediate liquid and solid reagents using HMI/SCADA/MES interfaces.
  • Accurately weigh and dispense biological and synthetic chemicals/raw materials for reagent formulation.
  • Work under the oversight of an approved Trainer to efficiently gain knowledge and execute production activities according to approved manufacturing directions, ensuring compliance with SOPs and regulatory standards until certification is complete.
  • Operate in an ISO-certified cleanroom environment, following Good Aseptic Practices during processing and cleaning.
• Quality:
  • Complete all batch documentation Right First Time (RFT), ensuring accuracy, thoroughness, and timeliness.
  • Assist in the execution of validations, tech transfers, and scientific studies.
  • Maintain work areas in a clean, organized, and cGMP-compliant state.
• Operate cleaning equipment and record data accurately, using SOPs and documentation systems.
• Safety:
  • Adhere to all safety policies and procedures at all times.
  • Utilize appropriate Personal Protective Equipment (PPE) for both routine and non-routine tasks.
• Other Duties:
  • Utilize computer applications effectively.
  • Perform other duties as assigned by management.
  • Reasonable, reliable attendance and punctuality is an essential job function required for this position.
  • Ability to work extended and/or overtime hours as required to support production operations
  • Decisions within Formulation operations are critical to ensuring business continuity and minimizing the impact on production timelines and overall business outcomes. Each level of technician plays a vital role in maintaining seamless operations:
  • Execute actions essential to the efficient and compliant manufacturing of reagents.
  • Each decision directly contributes to maintaining production flow, upholding product quality, and protecting against potential business disruptions.

Education, Skills, & Experience:

• High School Diploma or GED with 0 years of relevant formulation experience in a regulated production/operations environment
• Experience in bulking and/or compounding within food, supplements, cosmetics, medical devices, or biopharmaceutical/chemical formulation is preferred.
• Familiarity with measurement scales, mixing, blending, bioreactors, upstream & downstream bioprocessing, fermenters, in-process testing instruments, chemical mills, and other formulation manufacturing equipment is strongly preferred.
• Knowledge of FDA and/or GMP regulations is an asset.
• Mechanical aptitude is preferred.
• Physical Requirements Include:
  
  • Remaining in stationary position, often standing, for prolonged periods.
  • Ascending/descending stairs, ladders, ramps, and the like.
  • Wearing PPE correctly most of the day. Ability to operate heavy machinery.
  • Adjusting or moving objects up to 50 pounds in all directions.