Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Shift: 12hrs Day or Night Shift on rotating 2/2/3 schedule
Pay: $27+/hr
Discover Impactful Work:
The candidate will help the performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will follow Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture). These functions may include but are not limited to activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors (50L - 2000L), and conducting large scale filtration or centrifugation.
A day in the Life:
Execution of manufacturing batch records, work instructions and/or SOPs, with focus on proactive 'right the first time' executions. Assist with batch record reconciliation
Assist in 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. Complete document reviews and revisions. Daily record review, tasks, and databases. Participate/Lead in shift exchanges, 1-1's, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities).
Support a quality investigation by answering questions and making suggestions for improvement.
Practices and promotes safe work habits and adheres to safety procedures and guidelines.
Critical evaluation of processes, including foresight and thinking ahead.
Ensure tasks are performed with a method of prioritization - interpret production schedules and complete tasks accordingly.
Education:
HS Diploma or equivalent required
Experience:
Required: Minimum of 2 years of work experience in manufacturing, operation, production, lab setting or related field
Preferred: Experience in a cGMP environment
Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred
Subject Matter Expert on upstream processing steps- preferred
Critical thinking and problem solving
Strong math skills
MS Office
Able to demonstrate practical knowledge with successful outcomes
Able to recognize problems developing, not just occurring
Able to read, write, and communicate in English
Able to understand and carry out instructions
Physical Requirements / Work Environment
Be willing to wear a full gowning suit which includes: bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions or hair care products, etc.)
Able to meet clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves
