Process Validation Specialist
3 days ago
Sagax Team is seeking a highly skilled Process Validation Scientist to support the development and execution of validation protocols, ensuring compliance with client and regulatory requirements.
Key Responsibilities:
- Develop and review validation protocols for release to manufacturing and operations teams.
- Collaborate with internal teams to ensure validation protocols align with regulatory requirements and client needs.
- Review batch records and ensure proper data collection for protocol alignment with fill/finish operations.
- Assist in report writing to meet client expectations and project deadlines.
- Ensure timely release of batch records and data for ongoing projects.
Requirements:
- Bachelor's degree in Biochemistry, Biology, or a relevant life science field.
- 7-10 years of experience in process validation, with expertise in upstream and downstream processes, as well as fill/finish operations.
- Previous experience in a Contract Development and Manufacturing Organization (CDMO) is preferred.
- Proven ability to write protocols and perform thorough batch record reviews.
- Strong attention to detail and experience working in a client-facing role.
- Ability to work effectively independently and in collaboration with cross-functional teams.
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