Manufacturing Technician
4 days ago
The Manufacturing Technician I will execute fundamental unit operations in downstream manufacturing related to the production of bulk drug substances in a multi-product facility.
This role involves performing tasks under limited supervision, adhering to standard operating and manufacturing procedures while maintaining compliance with cGMP regulations.
Key Responsibilities:- Execute fundamental operations such as parts cleaning, weighing and dispensing, equipment preparation, kit assembly, and staging with adequate training.
- Perform internal support duties, including stocking consumables/materials, updating controlled SOP binders, and discarding expired reagents.
- Recognize and report process and equipment anomalies to qualified staff.
- Assist with CIP and SIP of tanks and manufacturing equipment, as well as buffer preparation and transfer into tanks and bags.
- Conduct daily analytics and maintenance of analytical equipment.
- Clean and set up equipment according to established protocols.
- Document work in compliance with cGMP and cGDP standards.
- Report abnormalities and deviations in a timely and accurate manner.
- Adhere to safety standards and identify unsafe situations, escalating as necessary.
- Maintain production areas in accordance with predefined 5S standards.
- High school diploma; entry-level position.
- Associate's or bachelor's degree or biotechnology vocational training preferred.
- One or more years of experience in a cGMP-regulated industry preferred.
- Ability to work in a highly regulated environment, following all applicable SOPs, OCPs, and BGSs for cGMP, EHS, and compliance policies.
- Flexibility to adapt to a 24/7 shift structure with prior notice.
- Focus on executing repeatable tasks with moderate technical complexity.
- Basic interaction with Manufacturing Cell Culture, Purification, Compliance, Engineering & Technology, Supply Chain, Quality Assurance, and Quality Control.
- Strong attention to detail in a complex technical setup, with a Quality First mindset.
- Excellent written and verbal communication skills.
- Proficient with computer-based systems and able to read and understand SOPs and work instructions.
- Ability to collaborate effectively as part of a high-performing team.
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