Validation Engineer

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.