Senior Validation Engineer

4 days ago


Daly City, California, United States Katalyst Healthcares and Life Sciences Full time
About the Role

We are seeking a highly experienced Senior Validation Engineer to join our team at Katalyst Healthcares and Life Sciences. As a key member of our commissioning and qualification team, you will be responsible for ensuring the quality and accuracy of our facility and equipment systems.

Key Responsibilities
  • Technical Documentation: Develop and maintain technical documents associated with projects, including engineering and design specifications, protocols, and commissioning and validation documentation.
  • Commissioning and Qualification: Perform hands-on field execution of commissioning and/or validation documentation, ensuring that equipment and systems meet design requirements.
  • Quality Assurance: Review and verify equipment lists, instrument lists, drawings, specifications, and submittals to ensure quality, accuracy, and completeness.
  • Field Walk Downs: Conduct field walk downs to ensure installation meets design requirements and identify any deficiencies.
  • Deficiency Resolution: Identify and resolve deficiencies during installation and commissioning in a timely manner.
  • Mentorship and Training: Participate in the mentoring and training of junior engineers and contribute to the development of internal company policies and procedures.
Requirements
  • Education: Bachelor's degree in Engineering or a related discipline.
  • Experience: Minimum 8 years of experience in facility and equipment commissioning and qualification in the pharmaceutical, medical device, and/or biotechnology industry.
  • Skills: Strong utility and facility commissioning, qualification, and validation experience, with a focus on FDA compliance and cGMP.
  • Leadership: Proven ability to lead and manage teams, with excellent communication, leadership, and client loyalty skills.
  • Technical Skills: Proficient in Microsoft Office, including Word, Excel, PowerPoint, and Project, with the ability to quickly learn new computer applications.
What We Offer

As a Senior Validation Engineer at Katalyst Healthcares and Life Sciences, you will have the opportunity to work on challenging projects, develop your skills and expertise, and contribute to the success of our company.



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