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Validation Specialist V

Validation Technologies, Inc. (VTI) is a highly successful, growing Biopharmaceutical consulting company.  We are currently seeking a Validation Specialist for our client in the Framingham, MA area to work with the client in commissioning and qualification subject matter expertise. 

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:

  • Supports directly the CQV Lead for all related commissioning and qualification activities.
  • Commissioning and Qualification subject matter expert for biotech process equipment, utilities, and support equipment (e.g. autoclaves, parts washers, CTU, cold rooms).
  • Responsible for the review of supporting engineering documentation design and specification for all utility equipment and systems.
  • Collaboration with all other Engineering Team discipline leads as needed.
  • Support the C&Q role in development of Impact Assessments, Risk Assessments, and System Boundary of all facilities, utilities, systems, and equipment
  • Active participation in all Commissioning and Qualification related to the ICBF project with responsibility to lead deliverables as well as provide guidance for respective areas of expertise.
  • Prepare for execution design qualification, Critical Aspect Risk Assessments, FATs, SATs and Qualification as required.
  • Ensure that the Sanofi HSE, Quality and Engineering standards and practices are met or addressed, and the safety and quality goals are met during the course of the Commissioning and Qualification Phase.

Requirements:

  • Upstream and downstream Biotech Process equipment, autoclaves, parts washer, HVAC, Chiller, Electrical, Cleanroom, WFI, Clean Steam, Gas Distribution, Process Plant waste system, automation commissioning and qualification knowledge and experience
  • Experience with GMP plant operation
  • Capital project experience
  • Strong organizational skills
  • Good interpersonal skills
  • Ability to thrive in a fast pace environment
  • Familiarity with applicable US and worldwide regulatory requirements.
  • Ability to read/interpret engineering drawings and design documents.
  • Excellent technical writing and verbal communication skills.
  • Proficiency in Microsoft Office including Word, Excel.

Skills:

  • Familiarity with applicable US and worldwide regulatory requirements.
  • Ability to read/interpret engineering drawings and design documents.
  • Excellent technical writing and verbal communication skills.
  • Proficiency in Microsoft Office including Word, Excel.

Education:

  • Bachelor's degree in engineering/science and 6+ years of validation experience or Master’s degree in engineering/science and 4 years of validation experience.  

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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