Formulation Tech 2-Night

Description

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.

Primary Duties:

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.

Education, skills and experience:

1. High School Diploma or GED and a minimum of 2 years of relevant formulation experience in a regulated production/operations environment, OR

2. Minimum of 2 years of equivalent military experience, OR

3. 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

4. Strong mathematical skills, with the ability to perform calculations with whole numbers, fractions, and decimals.

5. Ability to quickly learn and apply new procedures.

6. Ability to work efficiently toward goal completion in a complex, diverse environment with changing demands, using strong problem-solving, time management, and laboratory skills.

7. Experience in bulking and/or compounding within food, supplements, cosmetics, medical devices, or biopharmaceutical/chemical formulation is preferred.

8. 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.

9. Demonstrated interest in professional development, with the ability to learn new concepts quickly and a drive for results.

10. High attention to detail.

11. Ability to excel in a fast-paced, multi-tasking environment.

12. Adaptability to rapidly changing needs and priorities.

13. Strong verbal and written communication skills.

14. Familiarity with OSHA regulations (LOTO, electrical safety, etc.) preferred.

15. Knowledge of FDA and/or GMP regulations is an asset.

16. Mechanical aptitude is preferred.

17. Strong mathematical skills, with the ability to perform calculations with whole numbers, fractions, and decimals.

18. Ability to quickly learn and apply new procedures.

19. Must be able to demonstrate competency in operating new equipment within a 75-day training period.