Apex Systems Senior Production Technician in St. Louis, Missouri
Senior Production Technician in St. Louis, MO at APEX Systems
Date Posted: 1/5/2019
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- Employee Type:
St. Louis, MO
- Job Type:
Sci: Lab Tech
Up to 5 year(s)
- Date Posted:
Job Description Job #: 918425
Apex Life Sciences is looking for a Senior Production Technician!
The role is an overnight opportunity with guaranteed overtime!
The candidate will be responsible for the performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture) and Downstream (purification) pharmaceutical manufacturing. These functions may include activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors, conducting large scale chromatography, viral inactivation, viral filtration, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance.
Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a dayto-day basis and a focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.
Acts as On-The-Job-Trainer for a variety of job functions
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.
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
Execute validation protocols with minimal supervision or direction
Participate in cross-functional teams to complete projects
Participate in shift exchanges, 1-1’s, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities)
Lead shift exchanges and daily huddles for team as required. Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on a variety of techniques.
High school degree required. Bachelor’s degree in science or engineering preferred.
3-5 years of relevant experience in a related field or industry required
Understanding ‘why’ and not just the ‘how’ of processes and practices
Knowledge of cGMP practices required
Knowledge of deviation investigations preferred
Knowledge of chromatography, cell culture, and aseptic techniques strongly preferred
Mechanical Skills/ Analytical Skills/Method Automation
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178