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Validation Specialist III

VTI Life Sciences is a highly successful, growing Biopharmaceutical consulting company.  We are currently seeking a Validation Specialist III for our client in the Greater Scranton, PA area to work with the client to execute development studies (fermenter cleaning, media preparation, seed expansion, fermenter operation, sampling and analysis, waste disposal) and assisting with protocols, development of reports and data-packs. This position requires a mix of laboratory and validation experience.

VTI Life Sciences 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 Life Sciences 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.

Validation Responsibilities Include:

  • Working closely with subject matter experts (SME) to generate validation documents compliant with the site policies and procedures
  • Perform validation sampling and data analysis of the results
  • Ensure proper execution/documentation of test results, and compilation of validation packages.
  • Retrieve and compile data from electronic sources / databases and paper records
  • Responsible for authoring, reviewing, executing and approving validation documents
  • Assist in writing Standard Work Instructions and Batch Production Records
  • Leachable/Extractable Validation

Laboratory Technician Responsibilities Include:​

  • Execution of development studies (fermenter cleaning, media preparation, seed expansion, fermenter operation, sampling and analysis, waste disposal) and maintaining thorough records in lab notebooks [80% time]
  • Assisting with protocols, development reports and data-packs [20% time].
  • Execution of development studies (fermenter cleaning, media preparation, seed expansion, fermenter operation, sampling and analysis, waste disposal) and maintaining thorough records in lab notebooks [80% time]
  • Assisting with protocols, development reports and datapacks [20% time].

Skills:

 

  • Hands-on biological laboratory operations
    • Adherence to safety and cGLP procedures; use of PPE
    • Basic writing and communication skills

Proficient in:

  • MS Office 2010 MS Word, Excel, PowerPoint and Outlook
  • EDoc with a working knowledge of templates, workflows and approval process
  • Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Cleaning Validation
  • Technical writing abilities and time management skills. 
  • Strong root cause analysis skills with cGMP experience. 
  • To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
  • Interact well with a diverse group of individuals.
  • Self-motivated and willing to be proactive in resolving issues
  • Demonstrate the ability to successfully interface with QA personnel.
  • Excellent Verbal and written communication skills.   Ability to work in a team environment.
  • Leachable/Extractable Validation

VTI Life Sciences Offers:

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI Life Sciences 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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