What are the responsibilities and job description for the Sr. Validation Engineer position at TekOne IT Services Pvt. Ltd.?
Job Title: Sr Validation Engineer
Location: Plymouth, MN | Princeton, NJ | Irving, TX (W2 Contract)
Key Responsibilities
Location: Plymouth, MN | Princeton, NJ | Irving, TX (W2 Contract)
Key Responsibilities
- Lead the development and execution of validation protocols, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) for equipment and processes.
- Design, plan, and implement validation strategies for new and existing processes to ensure they meet regulatory requirements (FDA, ISO 13485, EU MDR, etc.).
- Collaborate with cross-functional teams (Quality, Engineering, Production) to identify and mitigate risks through validation activities.
- Author and review validation plans, protocols, and reports, ensuring accuracy and compliance with regulatory standards and company policies.
- Conduct process validations, method validations, cleaning validations, and equipment qualifications.
- Investigate deviations and non-conformances that occur during validation activities and develop corrective and preventive actions (CAPAs).
- Support regulatory submission activities by providing validation documentation and technical support.
- Maintain up-to-date knowledge of industry regulations and standards and ensure all validation processes comply with them.
- Participate in the continuous improvement of validation processes, including identifying areas for efficiency and compliance enhancement.
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 4 years of experience in validation engineering within the medical device industry.
- In-depth knowledge of FDA regulations, ISO 13485, and other relevant medical device standards.
- Experience with process validation, equipment qualification, method validation, and cleaning validation.
- Strong technical writing skills for developing validation protocols, reports, and SOPs.
- Proficiency in validation tools and statistical analysis software.
- Ability to work in a regulated environment and maintain strict adherence to quality standards.
- Excellent communication skills and ability to work collaboratively with cross-functional teams.
