Job Description
CONTRACT: 6-month extendable
MUST HAVES:
- High school education or GED required. AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred.
- 1+ years experience with media preparation and transfers, cell culture workflows, cleanroom operations, equipment sanitization, and/or environmental monitoring
Schedule:
- Candidates must be flexible to work 7:00am-3:30pm and/or 3:00-11:00pm EST shifts starting mid-August (full production period).
- During full production period, candidates must be flexible and able/available to work OT hours if needed, some weekend work, and any holidays that occur during production period
Position Overview:
Focused on execution of cGMP manufacturing activities required to deliver the production plan reliably and compliantly. Essential functions of the job include but not limited to:
- Follow cGMP procedures to support manufacturing execution and automated recipes
- Media preparation & transfers / filtration
- Cell culture sampling, monitoring & transferring
- Harvest operations
- Equipment & process troubleshooting
- Deviation identification, reporting
- cGMP procedure development and optimization
- Requesting, staging, and verifying materials for production activities
- Completing batch documentation and reviewing records for accuracy
- Supporting routine cleanroom operations, equipment sanitization, and environmental monitoring
- Cleaning of the facility
- Collection of samples for environmental monitoring
- Removal of process waste
- Operation of Distributed Computer System (DSC)
- Operation of equipment’s such as Clean-in-Place (CIP), Steam-in-Place (SIP) skid, Caustic skid, autoclave, part washer, filter integrity tester, biowelders, etc.
Skills:
- Evidence of good verbal and written communication.
- Ability to work in fast paced dynamic environment with competing priorities.
- Demonstrated ability to collaborate within and between diverse groups.
- Proactive identification and implementation of continuous improvement opportunities.
- Aptitude for learning moderately complex technical systems.
- Able to receive and incorporate feedback – passion for ongoing professional development a plus.
- Must be able to stand for long periods, up to 8 to 10 hours/day.
- Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
- Must be able to work scheduled 40 hours with the ability to work overtime as needed.
- Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.
- Upstream manufacturing
- Use of single use bioreactor systems
- Willing to work any shift.
Education:
- At least 1 year of relative experience required.
- High school education or GED required.
- AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred.