#x 9; Support the Quality Engineering group with documentation and validation needs. Draft URS documents, design specifications, testing protocols, and final reports. Perform hands on validation execution for automation implementation project. Draft protocol discrepancy reports and support resolution. Review and approval of validation documents. Utilize specified document review / approval process to submit specifications, forms, and protocols for approval. Establish schedules with vendors and i... more details
Kelly® Science & Clinical is seeking a Contract Sr. Validation Engineer at a cutting-edge Therapeutics Company client in the Los Angeles Area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay Rate: $60-70/hr DOE
Contract Length: 2.5-4 months
Overview In this role as ContractSr. Validation Engineer, you’ll be providing validation activities in both manufacturing and quality supporting the team working toward developing the next generation of cell therapies
Schedule: M-F 8AM -5PM OT and weekends may be required as necessary. 100% on-site
Responsibilities:
Support the Quality Engineering group with documentation and validation needs.
Draft URS documents, design specifications, testing protocols, and final reports.
Perform hands on validation execution for automation implementation project.
Draft protocol discrepancy reports and support resolution.
Review and approval of validation documents.
Utilize specified document review / approval process to submit specifications, forms, and protocols for approval.
Establish schedules with vendors and internal departments as needed.
Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc.
Attend Project meetings and relay project status as required.
Write / review equipment and computer system documentation – specifications, C&Q test protocols, final reports, and route for approval as required.
Scheduling equipment and computer systems validation execution and documentation activities in accordance with project priorities.
May perform project management and other tasks, as needed.
Qualifications:
Bachelor’s Degree and 5+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations
Experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems preferred.
Possess in-depth knowledge of cGMP and regulations related to biotech / pharmaceutical qualifications.
Able to work collaboratively and cross-functionally with other departments and vendors
What happens next: Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in the Kelly Science & Clinical network. That means our team of expert science & clinical recruiters will have access to your profile, making your opportunities limitless.
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