Pharmaceutical Production Technician - #604127
Date: 11/25/2021 21:30 PM
City: Brighton, Michigan
Contract type: Full Time
Work schedule: Full Day
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:
- Follow detailed, written instructions (Manufacturing Batch Record, MBR) and procedures (Standard Operating Procedures, SOPs)
- Accurately complete production documentation in performance of manufacturing operations.
- 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.
- Ensure quality standards and best practices are followed throughout the manufacturing process.
- Maintain functional understanding of cGMP's and the impact of deviation from controlled processes and/or procedures. Participate in investigations as needed.
- Perform equipment change-over, set-up, and cleaning for manufacturing processes.
- Maintain a clean, orderly work environment that remains stocked with materials and supplies.
- Troubleshoot basic mechanical operations/equipment in support of manufacturing unit operations.
- Operate and navigate equipment functionality through routine interaction with a Human-Machine Interface (HMI) or Supervisory Control and Data Acquisition (SCADA) systems.
- Utilize manufacturing knowledge and experience to revise and improve procedures and processes
- Perform batch documentation review during manufacturing operations. Review batch documentation during revisions or modifications.
- Train/mentor less experienced operators.
- Represent production in meetings (project, scheduling, investigation review, etc.) as needed.
- Demonstrate general knowledge and consistent practice of good aseptic technique.
- Perform other duties as required.
Specific Position Duties and Responsibilities:
- Verify identity and quantity of components/materials for use in manufacturing.
- Input data into and navigate automated control systems.
- Initiate and monitor equipment cycles (CIP, SIP, Decontamination, etc.)
- Record GMP data on controlled documentation accurately, precisely, contemporaneously.
- Review cycle charts / summary reports and make GMP decisions based on them.
- Transport hazardous and non-hazardous materials into/out of mfg area.
- Wash, sanitize, and utilize material carts / bins / totes.
- Complete and maintain training records within expected timelines.
- Identify and help implement process, procedure, safety improvements.
- Load and un-load materials into and out of rapid transfer ports, isolators.
- Assist other operators as well as maintenance personnel in equipment troubleshooting.
- Seek value-added tasks during unplanned downtime.
- Ability to develop corrective and preventative actions for process deviations.
- Strong work ethic and ability to accomplish tasks without supervision.
- Ability to understand abstract concepts, such as sterility, contamination, etc.
- Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting.
- Basic computer skills (proficient in Microsoft Office applications).
- Strong mathematical and organizational skills.
- English communication skills, both written and verbal.
- Must possess honesty and integrity, commitment to the highest legal and ethical standards
- Ability to treat every person with courtesy and respect
- Demonstrate ownership and accountability to production schedule without compromising product quality
- Desire to work with others and share best practices with colleagues on their shift and on other shifts
- Knowledge of fundamental cGMP and regulatory principles
- The Production Technician position requires the ability to
- Routinely lift up to 50 pounds
- Stand for periods lasting up to 6 hours of an 8-hour shift
- 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