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- San Diego, CA
- Simone Brandalise
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Sr. Downstream Manufacturing Tech
Aerotek • San Diego, CA
Posted 5 days ago
Job Description: Technical
Perform GMP manufacturing activities in assigned areas
Follow SOPs, cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality product.
Set-up, operate, maintain and clean downstream bioprocessing equipment, which include but not limited to chromatography system, UF/DF and Viral filtration skid and mixers.
Demonstrate good aseptic technique
Basic troubleshooting of bioprocess equipment
Perform manual cleaning and sterilization of parts and components
Able to work flexible hours and overtime
Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices.
Draft and revise SOPs and batch records
Address production issues and report any compliance related concerns to supervisor
Work Environment: Tolerance of frequent exposure to chemicals and solvents
Standard Lab and Pilot Plant environment
Biologics GMP manufacturing environment
Prolonged standing on manufacturing floor
Ability to stoop, bend, kneel, reach and move freely throughout manufacturing areas
Ability to move of heavy equipment and the ability to lift ~50 pounds
High School with 2 plus years experiences in biotech/pharmaceutical industry. AA/AS, Bachelor's degree preferred
2 plus years Downstream experience, proficient in Protein Chromatography, TFF, Viral Filtration, Bulk Drug Substance Final Filtration, Depth Filtration. Aseptic Sampling of process pools and buffers.
Experience with Unicorn, CCP
Available to work a split shift when process requires.
Buffer Preparation, Tubing assemblies and Autoclaving.
cGMP manufacturing for biological product required
Proficient with Microsoft Word and Excel, Master Control
Ability to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
SOP and Batch Record revision and creation.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.