US Citizens or Greencard Holders only*
No C2C
Work Schedule : Onsite - M-F
Salary : $60-80 / hr
Duration : 4 months
Primary 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.
- Escalate issues to leadership as needed.
- 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
- Knowledgeable in various areas of equipment and computerized systems with strong understanding of data integrity, life cycle approach, and change control management.
- Self-motivated / disciplined.
- Experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems preferred.
- Strong interpersonal communications skills with excellent technical writing abilities.
- Demonstrated application of engineering principles on projects.
- Possess in-depth knowledge of cGMP and regulations related to biotech / pharmaceutical qualifications.
- Proficient in Microsoft Office tools (Power point, MS Project, Excel, and Word).
- Able to work collaboratively and cross-functionally with other departments and vendors
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