Formulation Tech 2

Title of Direct Supervisor: Manufacturing Production - Management 1

Position Summary

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.

Responsibilities:

• Executes Formulation Operations and Documentation under Trainer until certified. Once certified, this role may operate independently or as part of a team with minimal supervisory oversight.
• Performs or assists in the setup, operation, inspection, preventive maintenance, troubleshooting, and cleaning of equipment used throughout the BACT/ALERT formulation processes. Equipment includes, but is not limited to, solution preparation tanks, bio-reagent mixing vessels, assembly preparation stations, filters, balances, pumps, pH/conductivity meters, CIP systems, parts washers, biosafety cabinets, and powder transfer/dispense systems.
• This role will typically Certify and Operate in up to 3 Formulation processes simultaneously, ensuring adherence to a demanding production schedule. Responsibilities include completing accurate documentation, obtaining and processing in-process samples (e.g., pH, conductivity, osmolarity, moisture analysis, TOC, visual inspection, and bioburden), monitoring and controlling processes, and reconciling materials for each batch.
• Collaborates with senior formulation staff, management, QA, and QC, to ensure compliance and success in meeting production goals.
• Maintains a strong sense of ownership over formulation processes, equipment, and the work environment, fostering a proactive approach to quality and efficiency in all operations.

Local Primary Duties

• 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.
• 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.
• 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.
• Participate in Safety Gemba Walks, HSE audits, and actively contribute to enhancing the department’s safety culture.
• Utilize computer applications effectively.
• Generate reports, charts, and KPIs.
• Perform all work in compliance with company quality procedures and standards.
• Performs other duties as assigned.

Qualifications

Required Education, Training and Experience

• High School Diploma, GED or equivalent
• 2 years of formulation experience in a regulated production/operations environment required OR 2 years of equivalent military experience 

Preferred Education, Training and Experience

• BioWorks, LEAN or other Continuous Improvement Certificate preferred
• 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.
• Strong mathematical skills, with the ability to perform calculations with whole numbers, fractions, and decimals preferred.
• Familiarity with OSHA regulations (LOTO, electrical safety, etc.) preferred.
• Mechanical aptitude is preferred.

Key Skills, Knowledge and Abilities (KSAs)

• Detail orientation to complete tasks without errors and produce high-quality work.
• Informing others by sharing clear, timely information to ensure alignment.
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives.
• Effective verbal communication skills.
• Easily accessible and open to communication.
• Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes.

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: 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.
• The job utilizes equipment and processes which include mechanical hazards, electricity hazards, and tripping / falling hazards.