Bryllan LLC
  • 19-Mar-2018 to 18-May-2018 (EST)
  • Operations
  • Brighton, MI, USA
  • Full Time

The duties of the Production Technician cover all aspects of production, including but not limited to: Dispensing,
Formulation, Aseptic Filling, and Packaging. 
The Production Technician ensures a clean, safe workplace and quality production of drug product adhering to current Good Manufacturing Practices. (CGMP's).

A Production Technician is a member of the Operations team, responsible for the safe, efficient, and routine manufacturing of drug product. 

 Essential Duties and Responsibilities:

  1. Follow detailed, written instructions (Manufacturing Batch Record, MBR) and procedures (Standard Operating Procedures, SOPs)
  2. Accurately complete production documentation in performance of manufacturing operations.
  3. Practice and promote safe work habits while performing job functions through the safe use of equipment in compliance with established company and regulatory safety requirements.
  4. Ensure quality standards and best practices are followed throughout the manufacturing process.
  5. Maintain functional understanding of cGMP's and the impact of deviation from controlled processes and/or procedures.  Participate in investigations as needed.
  6. Perform equipment change-over, set-up, and cleaning for manufacturing processes.
  7. Maintain a clean, orderly work environment that remains stocked with materials and supplies.
  8. Troubleshoot basic mechanical operations/equipment in support of manufacturing unit operations.
  9. Operate and navigate equipment functionality through routine interaction with a Human-Machine Interface (HMI) or Supervisory Control and Data Acquisition (SCADA) systems.
  10. Utilize manufacturing knowledge and experience to revise and improve procedures and processes
  11. Perform batch documentation review during manufacturing operations. Review batch documentation during revisions or modifications.
  12. Train/mentor less experienced operators.
  13. Represent production in meetings (project, scheduling, investigation review, etc.) as needed.
  14. Demonstrate general knowledge and consistent practice of good aseptic technique.
  15. Perform other duties as required.

 

Specific Position Duties and Responsibilities:

  1. Verify identity and quantity of components/materials for use in manufacturing.
  2. Input data into and navigate automated control systems.
  3. Initiate and monitor equipment cycles (CIP, SIP, Decontamination, etc.)
  4. Record GMP data on controlled documentation accurately, precisely, contemporaneously.
  5. Review cycle charts / summary reports and make GMP decisions based on them.
  6. Transport hazardous and non-hazardous materials into/out of mfg area.
  7. Wash, sanitize, and utilize material carts / bins / totes.
  8. Complete and maintain training records within expected timelines.
  9. Identify and help implement process, procedure, safety improvements.
  10. Load and un-load materials into and out of rapid transfer ports, isolators.
  11. Assist other operators as well as maintenance personnel in equipment troubleshooting.
  12. Seek value-added tasks during unplanned downtime.
  13. Ability to develop corrective and preventative actions for process deviations.

 

Behavioral Expectations:

  1. Strong work ethic and ability to accomplish tasks without supervision.
  2. Ability to understand abstract concepts, such as sterility, contamination, etc.
  3. Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting.
  4. Basic computer skills (proficient in Microsoft Office applications).
  5. Strong mathematical and organizational skills.
  6. English communication skills, both written and verbal.
  7. Must possess honesty and integrity, commitment to the highest legal and ethical standards
  8. Ability to treat every person with courtesy and respect
  9. Demonstrate ownership and accountability to production schedule without compromising product quality
  10. Desire to work with others and share best practices with colleagues on their shift and on other shifts
  11. Knowledge of fundamental cGMP and regulatory principles

Physical Requirements:

  1. The Production Technician position requires the ability to
    1. Routinely lift up to 50 pounds
    2. Stand for periods lasting up to 6 hours of an 8-hour shift
    3. Properly gown for entry into the controlled manufacturing area

 

Work Expericene and Educational Requirements

A Bachelor of Science (BSc) in Life Sciences or Engineering with 0 2 years' experience in Pharmaceutical or Medical environments

 An Associate's Degree with 2 4 years' experience in Pharmaceutical or Medical environments

 A High School Diploma or GED with 5 6 years' experience in Pharmaceutical or Medical environments

Bryllan LLC
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