Validation Engineer
Validation Engineer
Posted on :
18-07-2025
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1 Vacancy
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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:
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 (e.g. CSV BFU Qualification).
- Bachelors 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.
Employment Type
Full-time
Key Skills
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