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Validation Specialist
Ref No.: 19-12974
Location: Swiftwater, Pennsylvania
Sunrise System Inc. is currently looking for Validation Specialist in Swiftwater, PA with one of our top client.
 
Job Title: Validation Specialist
Job Id: 19-12974
Location: Swiftwater, PA 18370
Duration: 3 months
Position Type: Hourly contract Position (W2 only)
 
Duties
  • 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 review and analyze data
  • Cleaning Validation experience
  • Acceptance criteria determination
  • Sampling procedures, 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
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/GEODE+ experience with a working knowledge of templates, workflows and approval process
    Strong root cause analysis with cGMP 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/GEODE+ 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) with 4+ total years of experience working in a biologic, vaccine or pharma industry
Skills and Experience
  • CGMP
  • Filtration
  • General Computer Skills
  • Root Cause Analysis
  • Analytical Chemistry
Additional Skills
  • Biochemical
  • Biochemistry
  • Chemistry
  • Documentation
  • Excel
  • GMP
  • Microsoft Excel
  • Microsoft Outlook
  • Microsoft Word
  • Outlook
  • QC Testing
  • Risk Assessment
  • Sampling
  • Shipping
  • Sterilization
  • Word
 
Contact
Pooja Sinha
Direct: (732) 272 - 0316 | Email: pooja.s@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com