- Perform tasks of the production operation specific to bulk formulation and aseptic filling line support.
- Maintains batch record documentation and logs as required by corporation and regulatory agencies.
- Performs cleaning and sanitizing of production equipment and classified production space.
- Prepares, according to procedures, various stock solutions and buffers as required by the production process.
- Prepares equipment, glassware, filters, etc. required for production.
- Assists in process and system validation activities as required.
- Will serve as witness of routine unit operation tasks for batch record signing. Receives instructions on all assignments with supervision. Takes initiative to identify issues and keep leads / management informed.
- Independently performs product sampling, environmental monitoring, or other related activities as directed.
- Independently performs routine tasks in the areas of Aseptic Syringe Filling. This includes but it is not limited to Operation of the syringe filling while monitoring critical parameters as per procedures.
- HS Diploma required; AA degree in related discipline preferred
- Experience working in GMP environment highly desired
- Prior document revision of SOPs and BPRs experience and experience reviewing BPRs is preferred.
- Prior mechanical experience and experience working as an Aseptic Production operator is preferred.
- Knowledge of formal FMEAs, RAs, CAPAs, CCRs, NCRs, and Action Items helpful
- Applies acquired skills while performing the most complex tasks of the position, following established practices and procedures.
- Demonstrated ability to apply experience to perform equipment troubleshooting, monitor employee activities and to make procedural revisions, as needed. Implements and maintains production schedules based upon intra-departmental information.
- Ability to ensure compliance with GMPs and SOPs.
***For immediate consideration, please email your updated resume to email@example.com with 'Manufacturing Technician NJ' in the subject line.