About this opportunity :As a Manufacturing Technician III, you'll be responsible for the implementation of assigned production operations working within defined production schedules in a cGMP environment. This is a 2nd shift position and comes with a 15% shift differential.
Key Responsibilities: - May specialize in either purification or synthesis processes.
- As required, may cross train on basic or non-technical operations associated with other functions within the company.
- Maintain a clean and organized work environment in accordance with defined procedures.
- Assist Process Support Group in the execution of special projects and data collection.
- Demonstrate proficiency on the execution of key manufacturing processes which may include all or portions of the following: synthesis, cleavage and deprotection, chromatography, ultrafiltration , or freeze-drying
- Qualify lower levels on key manufacturing processes.
- May act as a lead for any given campaign.
- Review of basic cGMP documentation including solution and raw material reconciliation.
- Develop, review and revise SOPs and PIs to assure documentation reflects current operations.
- Qualify on basic investigational documentation including OOT, SHE, and CAPA's.
- Revise generic documentation to keep up with industry standards and customer expectations.
Required Skills/Abilities: - Minimum education requires high school diploma or equivalent with college level chemistry or equivalent work experience. A biotechnology certificate or college degree is preferred.
- Must have knowledge of basic laboratory instrumentation such as use of pH meter, UV instrumentation, and solution delivery systems (process skids).
- Must have knowledge of relevant manufacturing processes which may include chemical synthesis, chromatography, ultrafiltration, freeze-drying, and aseptic technique.
- Experience in cGMP manufacturing environment.