What are the responsibilities and job description for the Validation Engineer position at KKR Consulting?
Key Responsibilities :
- Validation Protocol Development : Develop, execute, and document comprehensive validation protocols for equipment and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Regulatory Compliance : Conduct thorough gap analyses to ensure compliance with industry regulations such as FDA 21 CFR Part 211, GMP, and ICH Q10, ensuring that processes meet or exceed required standards.
- Risk Management : Perform risk assessments in alignment with ISO 14971 guidelines, creating and maintaining risk management files to address potential issues proactively.
- Process Optimization : Identify opportunities for process improvements, aiming to enhance manufacturing and testing efficiency without compromising product quality.
- Cross-Functional Collaboration : Work closely with teams across R&D, Quality, and Manufacturing to ensure seamless process improvements and successful technology transfers.
- Verification Protocols and Reports : Lead the development and execution of verification protocols and detailed reports, ensuring alignment with product specifications and regulatory requirements.
- Audit Support : Assist in internal and external audits by preparing and providing thorough validation documentation. Address and resolve any non-compliance issues identified during audits.
- Troubleshooting and Corrective Action : Identify root causes of process deviations and work collaboratively with teams to implement corrective actions, ensuring effective resolution and compliance.
Qualifications and Skills :
