Manufacturing Technician 1 (1st Shift)

Description

QC Lab or cell culture oriented.

Manager would like to see new resumes with environmental monitoring or utilities sampling.

Additionally, aseptic technique sampling experience in GMP environment.

Work Schedule

• 7am - 3:30pm: Mon-Fri (OT and Holidays as needed)

Comments:

• Free Parking onsite
• Open to candidates willing to relocate at own expense
• OT and holidays required
• Lifting max up 35 pounds injury, frequent lifting tote, cart
• Will work team of 7 individuals
• Possible extension
• Exposure to heat (hot water) autoclave, and cold rooms they will go in every day
• Exposure to chemicals/ cleaning solution, ISO alcohol spore cleanse, Process NPD One Step germicidal detergent

Must have:

• Min 2 years of manufacturing experience
• Familiar with GMP documents/GDP Good documentation practices

Nice to have skills:

• SAP would plus!
• Prior sampling experience, environment or water sampling
• Aseptic technique sampling experience in GMP environment

Summary:

• This position is responsible for ensuring all sampling are collected within the required frequency.
• Sampling includes environmental monitoring and utilities sampling in cGMP areas.
• The position is also responsible for preparing all the material needed for the manufacturing process.
• Preparation includes Glassware washing, Transfer Assembly preparation and Autoclaving.

Responsibilities:

• Execute standard operating procedures (SOPs) in routine/non-routine sampling process in areas of the cGMP manufacturing facility.
• Perform aseptic sampling (Environmental monitoring sampling, WFI (water injection), PUW (Purified Water) and Clean Steam Sampling)
• Prepare material for manufacturing process (Glassware washing, Transfer Assembly preparation and, Autoclaving)
• Perform routine cleaning of the cGMP facility.
• Interact with other departmental personnel to assist in resolving manufacturing quality issues.
• Maintain records and documentation in accordance with a cGMP environment
• Work a flexible work schedule, weekends and holidays as required.
• Follows instructions on notification of deviations as they occur and provides information during investigations.
• Must be able to support additional manufacturing activities as needed.

Requisite Education/Skills:

• Education: High School degree with at least two years of experience or training in a cGMP manufacturing environment
• Aseptic technique sampling experience in GMP environment is preferred
• Strong content knowledge in cGMP/regulatory compliance.
• English fluent, both written and spoken
• Good communication and social skills