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Title
Text copied to clipboard!Validation Engineer
Description
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We are looking for a Validation Engineer to join our team and ensure that our systems, equipment, and processes meet all regulatory and quality standards. The Validation Engineer will play a critical role in the development and manufacturing of products by ensuring that all systems are properly tested and validated before they are released for production or use. This role requires a strong understanding of engineering principles, regulatory requirements, and quality assurance practices.
As a Validation Engineer, you will be responsible for developing validation protocols, executing validation tests, and documenting results in compliance with industry standards and regulations such as FDA, GMP, and ISO. You will work closely with cross-functional teams including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to ensure that validation activities are aligned with project goals and timelines.
The ideal candidate will have experience in validation within a regulated industry such as pharmaceuticals, biotechnology, or medical devices. You should be detail-oriented, analytical, and capable of managing multiple validation projects simultaneously. Strong communication and documentation skills are essential, as you will be required to prepare detailed validation reports and present findings to internal and external stakeholders.
Key responsibilities include equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and computer system validation. You will also be involved in risk assessments, deviation investigations, and continuous improvement initiatives. A solid understanding of validation lifecycle, statistical analysis, and quality management systems is essential for success in this role.
This is an excellent opportunity for a motivated engineer to contribute to the quality and compliance of innovative products while working in a dynamic and collaborative environment.
Responsibilities
Text copied to clipboard!- Develop and execute validation protocols (IQ/OQ/PQ)
- Perform equipment, process, and cleaning validation
- Ensure compliance with FDA, GMP, and ISO standards
- Collaborate with cross-functional teams on validation activities
- Document validation results and prepare reports
- Conduct risk assessments and deviation investigations
- Support audits and regulatory inspections
- Maintain validation master plans and schedules
- Implement continuous improvement initiatives
- Train staff on validation procedures and best practices
Requirements
Text copied to clipboard!- Bachelor’s degree in Engineering, Life Sciences, or related field
- 3+ years of experience in validation within a regulated industry
- Knowledge of FDA, GMP, and ISO regulations
- Experience with equipment and process validation
- Strong analytical and problem-solving skills
- Excellent written and verbal communication skills
- Ability to manage multiple projects simultaneously
- Proficiency in Microsoft Office and validation software tools
- Familiarity with risk management and statistical analysis
- Attention to detail and strong documentation skills
Potential interview questions
Text copied to clipboard!- What types of validation projects have you managed?
- How do you ensure compliance with regulatory standards?
- Describe your experience with equipment qualification.
- What validation protocols are you most familiar with?
- How do you handle deviations during validation?
- Have you supported any regulatory inspections or audits?
- What tools or software do you use for validation documentation?
- How do you prioritize multiple validation tasks?
- Describe a challenging validation project and how you resolved it.
- What continuous improvement initiatives have you led or supported?
