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Validation Lead III
Ref No.: 18-06386
Location: Swiftwater, Pennsylvania
Position Type:Contract
Start Date / End Date: 05/01/2018 to 04/30/2020
Sunrise System Inc. is currently looking for Validation Lead in Swiftwater, PA with one of our top client.
Job Title: Validation Lead
Job Id: 18-06386
Location: Swiftwater, PA 18370
Duration: 24 months
Position Type: Hourly contract Position (W2 only)
Duties
  • 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 
Skills
  • 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 
Education
  • BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical) with6-9 total years of experience working in a biologic, vaccine or pharma industry. 
Contact
Savitha Divakaran
Direct: (732) 272 0299 | Email: Savitha.D@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com