Manufacturing Technician I
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.
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