Pharmaceutical Production Technician (Afternoon Shifts)

Are you interested in an exciting and rewarding career within a growing company? Are you eager to learn and motivated to collaborate with a team to achieve goals? Do you have passion for improving the lives of others?

Biovire is looking for respectful, empathetic, courageous individuals who are eager to utilize their skills in a rewarding career. Bring the knowledge and experience you've gained from your education and career, along with willingness to continuously learn in the pharmaceutical manufacturing industry. Biovire in Brighton, Michigan, is a contract manufacturing organization (CMO) with a focus in sterile injectable pharmaceuticals. Biovireembraces a management philosophy built around the principles of Quality, Integrity, and Service. If you feel invigorated by the thought of contributing to the creation of life enhancing or lifesaving products, this opportunity could be for you!

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 Experience and Educational Requirements:

• A High School Diploma or GED

• Bachelor of Science or equivalent industry experience preferred but not required

Compensation Package:

• Afternoon Shift (3pm - 11:30pm): $20-$22/hour 10% shift premium
• Paid Time Off
• Medical, Dental, & Vision insurance
• Short-term and long-term disability insurance

Employment at Bryllan (Biovire) is contingent upon a successful Background check.

Salary : $20 - $22