Validation Engineer
Thermo Fisher Scientific Inc.
 Santa Clara, CA

Job ID :

106685BR

Location :

US - California - Santa Clara

:

Job Description

Position Title: Validation Engineer

Requisition ID: R-00888780

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

Santa Clara Bioproduction Division. This position is located in Santa Clara.

How will you make an impact?

Being part of the validation team, you will responsible for the validation & qualification of our TruBio software and integrated Bio processing equipment. To ensure they meet customer regulatory requirements.

What will you do?

  • Assessing and defining assigned validation project deliverables.
  • Writing, reviewing, and execute of project validation protocols for standard & customized systems.
  • Leading qualification executions, working closely with customers during FAT and site qualification
  • Raise discrepancies and close out test documentation.
  • Prepare validation summary reports for executed protocols
  • Conduct deviation investigations, such as validation failures, complaints and hold investigations. To Identify & implement the appropriate corrective actions.
  • Attend client sites to support the C&Q effort US & Worldwide 25-30% travel.
  • Troubleshoot technical issues and execute corrective actions.
  • Act as point of contact for C&Q with clients while site based.

How will you get here?

Education

  • BS or equivalent experience in engineering or another scientific field.

Experience

  • 5 years of hands-on validation experience with the development and execution of FAT, SAT, and IQ/OQ protocols.
  • Leading project qualification executions and close out.
  • Self-motivated, proactive, and capable of adhering to strict deadlines
  • Experience with DeltaV or similar automation system.
  • Minimum of 5 years' experience in control systems testing, preferably within the biotech or pharmaceutical sector.
  • Writing, reviewing, and execute of project FAT, SAT, and IQ/OQ protocols.

Knowledge, Skills, Abilities

  • Good understanding of GAMP, cGMP, GDP, and regulatory requirements for automated systems.
  • Computer Systems Validation
  • Attention to detail and ability to identify and remediation issues found during testing.
  • Highly effective verbal and written skills, including technical authorship.
  • Proficient in Microsoft Office, particularly Microsoft Word and Excel

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.