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Urgent! Validation Engineer Job Opening In Irvine – Now Hiring Katalyst HealthCares & Life Sciences

Validation Engineer



Job description


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.



  • Required Skill Profession

    Engineers



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