validation engineer
One of my clients is looking Role: Validation Engineer , if you’re interested or your skills matches, please share with me your updated resume to sushma@intellectt.com
Job Title: Validation Engineer
Location: Minnesota
Job Summary
We are seeking a skilled and experienced Validation Engineer to join our team. The ideal candidate will be responsible for ensuring that our products, processes, and systems meet regulatory and quality standards. This role involves planning, executing, and documenting validation activities for manufacturing and engineering processes to ensure compliance with industry standards.
Key Responsibilities
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, processes, and software.
• Collaborate with cross-functional teams (Quality, Manufacturing, R&D, and Engineering) to ensure validation activities are aligned with project goals.
• Analyze validation test results and provide recommendations for improvements or corrective actions.
• Create and maintain validation documentation including validation plans, protocols, reports, and change controls.
• Ensure compliance with regulatory requirements (FDA, ISO, etc.) and industry standards (GMP, GAMP, etc.).
• Troubleshoot and resolve issues identified during validation processes.
• Lead validation activities in new product development and process improvements.
• Work with suppliers and vendors to ensure the validation of third-party equipment and systems.
Required Skills And Qualifications
• Bachelor’s degree in Engineering, Quality, or a related field.
• 5+ years of experience in validation engineering, preferably in a regulated industry (e.g., pharmaceutical, medical devices, biotech, etc.).
• Strong knowledge of validation protocols (IQ, OQ, PQ) and regulatory standards (FDA, ISO, GMP).
• Hands-on experience with process validation, equipment validation, and software validation.
• Strong analytical skills and ability to troubleshoot and resolve complex issues.
• Experience with risk management, root cause analysis, and CAPA (Corrective and Preventive Actions).
• Excellent communication and documentation skills.
• Ability to work independently and within a team in a fast-paced environment.
• Strong project management skills and ability to manage multiple validation projects simultaneously.
Preferred Qualifications
• Certification in quality or validation-related fields (e.g., ASQ, Six Sigma, etc.).
• Familiarity with validation software tools and statistical analysis.
• Experience working in a highly regulated environment with stringent quality control measures.
Medical Equipment Manufacturing and Medical Practices
Quality Assurance
Contract