Vacancy caducado!
General Description:The Cell Culture Technician position will report directly to the manufacturing supervisor and support the following two phases of the Hopewell manufacturing facility start-up and steady state cGMP production:
Facility start-up and CQV (commissioning, quality, and validation) execution
Reliable high volume cGMP manufacturing
Required Skills/Attributes:
Demonstrated ability to collaborate well with diverse teams
Applications: Word, Excel, PowerPoint
Excellent verbal and written communication
Ability to consistently follow directions/instructions
Ability to work in fast paced dynamic environment with competing priorities
Passion for continuous improvement
Able to receive and incorporate feedback – passion for ongoing professional development a plus
Aptitude for learning moderately to complex technical systems
Drives for results
Responsibilities:
Provide process and equipment design input
Technical writing and document review
Design documents
Validation protocols
SOP’s, batch records & work instruction
Validation protocol execution and report generation
Equipment start-up, debug, and acceptance testing
Procedural design (SOP’s, MBR’s, etc.)
cGMP Manufacturing
Equipment cleaning and sterilization
Solution preparation and transfer
Deviation identification, reporting and record closure
Equipment and process troubleshooting
Sterile Filtration / Integrity testing
Good Documentation Practices
Analytical Instrumentation (pH, osmometer etc.)
Autoclaves and washers (equipment prep, cleaning and sterilization)
Bioreactor operations (single use: shaker flasks, wave and
Harvest operations
Sampling
Physical Requirements :
Must be able to stand for long periods, up to 8 to 12 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.
Must be comfortable in working in varying temperatures.
Frequent lifting, pushing, pulling, and carrying. Ability to lift to 40 lbs.
Regular reaching, bending, stooping, and twisting.
Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
Environment requires dedicated gowns, depending on area.
Work with hazardous materials and chemicals.
Willing to work any shift.
Education Required:
High school education or GED required
Preferred Bachelor’s degree
Prior industry or related field experienceComputer Skills: Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.Travel: International and domestic – periodically.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Vacancy caducado!