Manufacturing Technician

Description

USA-Manufacturing Technician I (Manufacturing/Quality) 1st Shift

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

• Free parking onsite, Open candidates willing to relocate at their own expense Possibility of extension Exposure to cold room
• Ability to lift up to 30 pounds Exposure to chemicals: hypochlorite, bleach, isopropyl alcohol Face mask is required when sampling, however no respirators are required for this role

Must have:

• 2+ years of hands-on experience in GMP environment similar role
• Previous Biotech or pharma required
• Must have combination of skills/ experience related to environmental monitoring, water sampling, glass wear prep, autoclave (not all required, however strongest candidates will have experience will most/ all of these skills)
• Will accept candidates with more than 2+ years of experience or bachelor’s degree or higher – they will not be considered overqualified
• SAP experience a plus
• MS Office Work Outlook
• Must be open to OT, holidays and possible weekends if needed, not a frequent occurrence, however as required due to business need.

Description:

• 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