Lyophilization Production Operator
- Posted: over a month ago
Lyophilization Production Operator – Aseptic Production
The Production Operator position is responsible for the operation of various types of processing and test equipment in environmentally controlled areas per Standard Operating Procedures. This includes but is not limited to being familiar with and troubleshooting, loading/unloading and lyophilization equipment. The Operator will use steam sterilizers, vial/parts washers, depyrogenation tunnel, formulation tanks and associated equipment, analytical balances, pumps, filter test equipment and other associated equipment. As part of these responsibilities, the Production Operator II monitors cycles and reviews data to ensure requirements have been met and completes all associated documentation.
Production Operator levels are differentiated based on the ability to perform tasks in various areas independently and with a high level of proficiency and knowledge of the area and equipment.
- High school diploma or equivalent
- 3+ years of related work experience in a Pharmaceutical environment working with cGMP Production operations
- 3+ years experience working with Lyophilization equipment
- Basic math and science skills and ability to use a computer
- Demonstrated ability to read, understand, interpret and apply technical writing and instruction
- Gowning Experience a must
- Experience with batch records review, auditing, and a broad understanding of pharmaceutical production
- Strong mechanical aptitude and root cause analysis, preferred
Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.
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