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Validation Lead

Validation Technologies, Inc. (VTI) is a highly successful, growing Biopharmaceutical consulting company.  We are currently seeking a Validation Lead for our client in the Greater Scranton, PA area to work with the client to assist in authoring, reviewing, executing, and approving validation documents.

VTI strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics, Medical Devices and Lifesciences industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment.  We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

 

Duties:

Experience in process validation and other broad spectrum 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
  • Serve as primary driver for completing activities
  • Ability to review and analyze data

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

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 (a plus)

 

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)  with 4+ total years of experience working in a biologic, vaccine or pharma industry

Validation Technologies Offers:

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices.  We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors.  www.validation.org

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