For companies:
For professionals:
For everyone:
Responsibilities
USA-Manufacturing Technician I (Manufacturing/Quality) 1st Shift.
7am - 3:30pm: Mon-Fri (OT and holidays as needed).
Free parking onsite. Open to 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; respirators are not required for this role.
Must have:
* 2+ years of hands-on experience in a GMP environment in a similar role.
* Previous experience in biotech or pharma.
* Combination of skills/experience related to environmental monitoring, water sampling, glassware preparation, and autoclaving (not all required; strongest candidates will have most or all of these skills).
* Candidates with more than 2+ years of experience or a bachelor’s degree or higher are acceptable; they will not be considered overqualified.
* SAP experience is a plus.
* MS Office, Outlook.
* Must be open to OT, holidays, and possible weekends if needed.
Description:
This position is responsible for ensuring all sampling is collected within the required frequency. Sampling includes environmental monitoring and utilities sampling in cGMP areas. The position is also responsible for preparing all materials needed for the manufacturing process, including glassware washing, transfer assembly preparation, and autoclaving.
Responsibilities:
* Execute standard operating procedures (SOPs) in routine and non-routine sampling processes in cGMP manufacturing areas.
* Perform aseptic sampling (environmental monitoring sampling, WFI, PUW, and clean steam sampling).
* Prepare materials for the manufacturing process (glassware washing, transfer assembly preparation, 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 cGMP requirements.
* Work a flexible schedule, including weekends and holidays as required.
* Follow instructions on notification of deviations and provide information during investigations.
* Support additional manufacturing activities as needed.
Requisite Education/Skills:
* High school degree with at least two years of experience or training in a cGMP manufacturing environment.
* Aseptic technique and sampling experience in GMP environment preferred.
* Strong content knowledge in cGMP/regulatory compliance.
* Fluent in English, both written and spoken.
* Good communication and social skills.
This job post is closed.