Senior Production Tech
Direct Staffing Inc
Senior Production Tech
Pharmaceutical / Biotech
Swiftwater Pennsylvania
Exp 2-5 yrs
Deg Bachelors
Occasional Travel
Job Description
The Senior Production Technician for VDL2 performs technical process operations for Developmental, Validation and Consistency lots for Phase 3 Clinical Trials, stockpiling, and commercial lots. Responsibilities include participation in cross-functional teams and routine day-to-day cGMP manufacturing activities while maintaining safety and compliance. To assure correct performance of process operations, additional responsibilities include EM monitoring, WFI/CS/Gas sampling, training, authoring of documents, general housekeeping as necessary and deviation/change control support. The Senior Production Technician is responsible to bring any process issues as well as corrective actions to these issues to Management's attention.
Working knowledge of Solution Prep, Large-scale Fermentation, Chromatography and/or TFF filtration operations is required. Experience with SAP, specifically entering work order notifications, entering pick lists and inventory management is also needed. Candidate must also be able to lead and perform day-to-day manufacturing operations with little to no supervision. Experience with the design and quality management of single use disposable components is a plus.
This position may also require personnel to flex into another platform within MTech and/or another IO department, as well as, the possibility to work weekends, holidays or off shift hours based on business needs.
Qualifications
BS in Science, Business or Engineering with 3-5 years cGMP Pharmaceutical manufacturing.
Minimum of 7 years cGMP Pharmaceutical manufacturing with no degree.
Direct Staffing Inc- Job-ID32940527Reference26-01625 Requirements: Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review. Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments...Senior
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