Formulation Tech 2 - Night Shift

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 normal working hours for this role are 7:00pm - 7:30am working a 2-2-3 rotation schedule.

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.*
  • Continue developing by cross-training in new areas of Formulation
  • Execute production activities efficiently according to approved manufacturing directions, ensuring compliance with SOPs and regulatory standards in the areas where 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.
  • Order, account for, cycle count, and reconcile all materials in SAP (ERP) while processing batches.
  • Support the review and revision of manufacturing directions, logbooks, batch reports, and SOPs related to reagent manufacturing.
• Safety
  • Adhere to all safety policies and procedures at all times.
  • Utilize appropriate Personal Protective Equipment (PPE) for both routine and non-routine tasks.
  • Participate in Safety Gemba Walks, HSE audits, and actively contribute to enhancing the department's safety culture.
• Other Duties
  • Utilize computer applications effectively.
  • Perform other duties as assigned by management.
  • Generate reports, charts, and KPIs.

Education, Skills, & Experience:

• High School Diploma/GED 2+ years of Formulation experience in a regulated production/operations environment is required.
  • Associate's Degree, BioWorks, LEAN or other Continuous Improvement Certificate with 1+ year of Formulation experience in a regulated production/operations environment is also accepted
  • Military experience will be accepted in lieu of Formulation experience
• 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.

#biojobs