Pay Range: $39 - $41.50 per hr. DOE.

Employee will operate on one of two shifts following a 2-2-3 schedule with the following hours: 7:00am-7:30pm on workdays that occur Sunday through Thursday and 7:00am-5:30pm on workdays that occur on Fridays and Saturdays. Weekends and holidays are required as scheduled.

Job Description:

Participate in process validation activities and ongoing manufacturing for a new multi-product manufacturing facility.

• Develop a suitable level understanding of GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
• Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the production floor.
• Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.
• Develop a Subject Matter Expert (SME) level understanding of GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.

Skills:

• Strong attention to detail.
• Ability to work safely in a manufacturing environment.
• Experience in aseptic operations required.
• Must be able to work in a clean room environment requiring special gowning including a face mask.
• Background in BSCs, isolators, aseptic gowning and qualification strongly desired.
• Experience with batch record execution, including good documentation practices.
• Individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds.

Education:

A minimum of 2+ years of experience in a cGMP manufacturing environment along with a degree in science or a technical related discipline OR a minimum of 3+ years of cGMP manufacturing experience with a high school diploma is required.