Validation Engineer

Katalyst Healthcares & Life Sciences • Irvine, CA

207d

About The Position

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.

Requirements

• Bachelor's degree in engineering or a related field.
• 4+ 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.

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 (e.g., CSV, BFU Qualification).

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree