PDS Tech Inc Operations Technician in Saint Louis, Missouri
PDS Tech is seeking candidates for an Operations Technician position in St. Louis, MO
How will you make an impact?
The candidate will be responsible for the performance of operations in support of GMP Cell Banking and BPS Cell Culture Teams. He/She will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (Cell Banking) biopharmaceutical manufacturing and Upstream (Cell Culture) operations. These functions may include but are not limited to activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, buffer and medium formulations, supply stocking and organization, bioreactor monitoring, and equipment maintenance including troubleshooting, cleaning, and performance of preventative maintenance.
What will you do?
Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.
Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.
Critical evaluation of processes, including foresight and thinking ahead.
Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
Forecast and resolve supply and raw material deficiencies. Identify and resolve scheduling conflicts with one week outlook.
Oversee and perform timely consumption of materials and completion of quality documentation in appropriate systems
Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. Work to complete documentation of deviations and events in appropriate systems
Participate in cross-functional teams to complete projects, including the BPS Cell Culture project teams
Participate in 1-1’s, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities).
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.