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Formulation Tech 2-Day

Formulation Tech 2-Day

bioMerieux Inc.Durham, NC, United States
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Description

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.

1. 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.
  • 2. 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.
  • 3. 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.
  • 4. Other Duties

  • Utilize computer applications effectively.
  • Perform other duties as assigned by management.
  • Generate reports, charts, and KPIs.
  • Supplemental Data :

    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.
  • Decide on the quantity and timing of bulk productions to align with manufacturing demands and avoid production delays.
  • Execute actions essential to the efficient and compliant manufacturing of reagents.
  • Assess when manufacturing or quality issues require escalation to senior staff or management to promptly address potential impacts on business continuity.
  • Each decision directly contributes to maintaining production flow, upholding product quality, and protecting against potential business disruptions.
  • Position Requirements :

    High School Diploma or GED

    Minimum of 2 years of relevant formulation experience in a regulated production / operations environment, OR

    Minimum of 2 years of equivalent military experience, OR

    BioWorks, LEAN or other Continuous Improvement Certificate, or an Associate's Degree with 1 year of relevant formulation experience in a regulated production / operations environment

    Knowledge, Skill and Abilities :

  • Strong mathematical skills, with the ability to perform calculations with whole numbers, fractions, and decimals.
  • Ability to quickly learn and apply new procedures.
  • Ability to work efficiently toward goal completion in a complex, diverse environment with changing demands, using strong problem-solving, time management, and laboratory skills.
  • 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.
  • Demonstrated interest in professional development, with the ability to learn new concepts quickly and a drive for results.
  • High attention to detail.
  • Ability to excel in a fast-paced, multi-tasking environment.
  • Adaptability to rapidly changing needs and priorities.
  • Strong verbal and written communication skills.
  • Familiarity with OSHA regulations (LOTO, electrical safety, etc.) preferred.
  • Knowledge of FDA and / or GMP regulations is an asset.
  • Mechanical aptitude is preferred.
  • Strong mathematical skills, with the ability to perform calculations with whole numbers, fractions, and decimals.
  • Ability to quickly learn and apply new procedures.
  • Must be able to demonstrate competency in operating new equipment within a 75-day training period.
  • Working Conditions :

    Ability to remain in 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.

    Physical Requirements :

    Performs all job functions and responsibilities in a safe and responsible manner.

  • Excellent personal hygiene required.
  • Reasonable, reliable attendance and punctuality is an essential job function required for this position.
  • Ability to operate motorized pallet jacks or forklift.
  • Ability to remain to stand for long periods of time while frequently being on the move and ascending / descending Stairs
  • Lifting, pushing, and pulling may be required for stocking and movement of equipment.
  • 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.
  • #biojobs

    Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https : / / careers.biomerieux.com / or contact us at [emailprotected] .

    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 (385) 770-1132, by email at [emailprotected] , or by dialing 711 for access to Telecommunications Relay Services (TRS).

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