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Role Summary
Production Technician I/II will operate processing equipment according to established SOPs in a cGMP environment, perform solution preparation, cell culture, purification and formulation, and support related activities. They will train with a qualified technician and follow cGMP documentation and Manufacturing Execution Systems (MES). They will contribute to problem-solving on the production floor and participate in continuous improvement initiatives as part of the manufacturing team.
Responsibilities
- Operate processing equipment according to established SOPs, MPRs, and SPRs in accordance with cGMPs.
- Perform solution preparation, cell culture, purification and formulation, and supporting activities.
- Train with a qualified Technician on activities related to operating process equipment (qualification required).
- Follow and execute cGMP documentation and utilize Manufacturing Execution Systems (MES).
- Contribute to problem-solving activities for non-routine activities on the production floor.
- Participate in continuous improvement activities for Manufacturing.
- Adhere to company values and behaviors.
Qualifications
- Required: Tech I — 0-1 yrs experience with High School Diploma.
- Required: Tech I — Ability to work independently or in collaboration with others on assigned tasks.
- Required: Tech I — Ability to comply with cGMP standards.
- Required: Tech I — Must possess computer skills.
- Required: Tech I — Ability to follow instruction and directions.
- Required: Tech II — 0-1 years experience with Bachelors, >1 year with Associates, >2 years with High School Diploma.
- Required: Tech II — Ability to work independently or in collaboration with others on assigned tasks.
- Required: Tech II — Ability to follow cGMP standards.
- Required: Tech II — Must possess computer skills.
- Required: Tech II — Ability to follow instruction and directions.
- Required: Tech II — Prior experience with aseptic/cGMP standards.
- Required: Tech II — Prior experience in Bioprocessing work environment/systems/equipment operation.
- Preferred: BS/BA degree.
- Preferred: Degree in STEM field.
- Preferred: Prior experience or exposure with aseptic/cGMP standards and environment.