Validation Specialist
Sanofi Pasteur Inc
Contract Swiftwater, Pennsylvania, United States Posted 1 year ago
About Position
Validation Specialist (Contract)
$60.00 / Hourly
Swiftwater, Pennsylvania, United States
Validation Specialist
Contract Swiftwater, Pennsylvania, United States Posted 1 year ago
Description
• Experience in cleaning validation in the biologics or vaccine industry to include the following:
Experience in authoring, reviewing, executing and approving validation documents
Interface with Quality organization and the ability to defend rationale in validation documents
Ability to develop cleaning cycle and lead the investigation or trouble shooting
Ability to review and analyze data
• Cleaning Validation experience
Acceptance criteria determination
Sampling plans and sample size determination
Rinse and Swab sampling experience
Bracketing and worse case rating
QC testing requirements
Dirty hold times and clean hold times
Responsibilities
- • Proficiency in utilizing documentation system to author protocols and reports
- • Experience participating in teams and collaborative work environments.
- • Good communication skills (verbal and written), math skills, general computer skills
- • Team environment a must
- • E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process
- • Strong root cause analysis with cGMP experience.
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