Compounder II, 1st shift - Renaissance Lakewood LLC

Primary Responsibility  for execution of bulk product batch processing, inclusive of all process related and administrative activities, as well as Equipment Preparation activities as declared in Compounder 1.

1. Follow manufacturing procedures to process bulk product. Batches to be made right the first time.
2. Follow manufacturing procedures specific to the task being performed.
3. Perform compounding functions as deemed necessary by operations management and functions where qualified to perform.
4. Operation of processing equipment, and the execution of manual and automated cleaning, sanitizing, and sterilization of tanks and equipment.
5. Perform integrity testing of filters using automated filter integrity test equipment.
6. Able to follow detailed diagrams and written instructions to assemble or disassemble equipment, configure equipment to be washed, configure equipment to be autoclaved.
7. Show progression in competency in all aspects of the position.
8. Demonstrate aptitude and capability to perform multiple tasks at the same time.
9. Able to successfully pass sterile gowning qualification within a 1 month time limit.
10. Aptitude to perform EM monitoring and testing of grade C and D clean rooms
11. Utilize knowledge to actively demonstrate process trouble-shooting capabilities whenever possible.
12. Ability to maneuver drums and equipment in excess of 50 lbs and the capability to lift weights up to 50 lbs.
13. Maintain accurate and complete documentation in fulfillment of all duties.
14. Understand and comply with current SOP and GMP requirements relevant to the position.
15. Maintain professional, courteous, and effective communication with all co-workers, customers, and contractors in the execution of all job functions.
16. Perform job responsibilities in a safe and efficient manner, maintaining a clean work environment. Assist supervisors and process manager in all other duties as assigned.
17. Proper use of personal protective equipment at all times is required.
18. Perform routine maintenance on process equipment.
19. Perform area cleaning to maintain compliance using phenolic cleaners and sporicidal agent. A full face respirator or PAPR will be required to be worn for this position.
20. Review MBRs throughout process to assure compliance to good documentation practices.
21. Be available for unscheduled and scheduled overtime throughout the work week and weekend when requested.

Prerequisites:
One of the following is required to be considered for the role of a Compounder II:
4+ years of relevant experience + High School Diploma
0 years of relevant experience + Bachelor’s Degree

Note: Demonstrated extensive understanding of the processes, procedures, safety practices, and quality initiatives as a Compounder I at Renaissance may qualify for a Compounder II with less experience listed as prerequisites.

Relevant Experience Considerations:
Relevant experience is defined by one or more of the following:
• Previous experience manufacturing product formulations and operating manufacturing related equipment (mixing tanks, pumps, homogenizers, etc.).
• Military leadership, logistics, mechanical experience, and/or training comparable to a manufacturing environment
• Trade school or work experience in some construction trades.
• Microbiology or Chemistry lab experience.

Aseptic manufacturing experience preferred.