Manufacturing Technician I

Location :

Pearl River

NY 10965

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.

Job 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.

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

Education/Experience:

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.