Manufacturing Technician I
19 hours ago
We are seeking a highly motivated and detail-oriented Manufacturing Technician I to join our team at Joulé. As a key member of our production team, you will be responsible for executing fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility.
Key Responsibilities- Execute fundamental unit operations in Downstream manufacturing, including parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging.
- Perform duties under limited supervision and according to standard operating and manufacturing procedures.
- Execute independently with adequate training non-complex fundamental operations.
- Perform internal support duties, including stocking consumables/materials, updating controlled SOP binders, and discarding expired reagents.
- Recognize and report process and equipment anomalies.
- Execute with oversight of qualified staff fundamental tasks, including CIP and SIP of tanks, manufacturing equipment, and buffer prep and transfer into tanks and bags.
- Daily analytics and maintenance of analytical equipment.
- Cleaning and setup of equipment.
- Document work according to cGMP and cGDP.
- Adhere to established regulations and follow cGMP established by site.
- Report abnormalities and deviations in a timely and accurate manner.
- Adhere to safety standards and identify unsafe situations/habits and escalate appropriately.
- Maintain production areas according to predefined standards (5s).
- High school degree, entry-level position.
- Associates/bachelors degree or biotechnology vocational training preferred.
- Preferable 1 or more years of experience in cGMP regulated industry.
- Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first time mindset.
- Strong written and verbal communication skills.
- Ability to work with computer-based systems.
- Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
- Eligible employees receive health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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