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Validation Lead III
Ref No.: 18-05411
Location: Swiftwater, Pennsylvania
Position is a Validation Lead III which is not currently on the rate card. Please use bill rate range (USD)86.02- 114/hr.
Experience in validation (process and or cleaning) 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 review and analyze data
Cleaning Validation experience
Acceptance criteria determination
Sampling procedures, plans and sample size determination
Bracketing and worse case rating
QC testing requirements
Dirty hold times and clean hold times
Process Validation
Mixing Validation
Establishing Critical Quality Attributes and Critical Process Parameters

Basic Qualifications:
Experience utilizing Microsoft Word, Excel, and Outlook
Experience writing and revising documents (e.g. testing methods, protocols, reports)
Experience performing testing in a GMP setting
MS Project experience
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 experience with a working knowledge of templates, workflows and approval process
Strong root cause analysis with cGMP experience.