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Validation Engineer
Validation EngineerKatalyst HealthCares & Life Sciences • Irvine, CA
Validation Engineer

Validation Engineer

Katalyst HealthCares & Life Sciences • Irvine, CA
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Job Description :

The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execution, and continuous improvement of validation processes across multiple sites, while supporting audits, risk assessments, and global quality initiatives.

Responsibilities :

  • Interpret and implement validation requirements based on FDA regulations, corporate standards, and site-specific procedures.
  • Represent validation activities during internal and external audits.
  • Participate in corporate validation teams to review and update global procedures and templates.
  • Lead the definition and execution of validation strategies across high-complexity projects.
  • Support and coach validation engineers and cross-functional teams in process development and validation best practices.
  • Develop and maintain systems to control changes to validated equipment or systems.
  • Drive validation efforts during mergers and acquisitions, ensuring alignment with corporate requirements.
  • Collaborate with teams involved in NPI, NPD, product transfer, and automation.
  • Champion and lead Lean / Six Sigma initiatives and continuous improvement projects.
  • Maintain expertise in at least two core validation disciplines (, CSV, BFU Qualification).

Requirements :

  • Bachelor's degree in engineering or a related field.
  • years of hands-on validation experience in a GMP-regulated medical device environment.
  • Strong knowledge of IQ / OQ / PQ protocols.
  • Direct FDA audit experience, with the ability to represent validation activities.
  • Expertise in Risk-Based Techniques (FMEA, FTA, Risk Management Framework).
  • Familiarity with statistical methods : sampling plans, R&R studies, process capability.
  • Demonstrated ability to write and own validation protocols and reports.
  • Strong analytical, problem-solving, and documentation skills.
  • Experience implementing Lean and Six Sigma tools (certification preferred).
  • Excellent written and verbal communication skills.
  • Comfortable working independently and in cross-functional teams.
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