Validation Engineer (Medical devices)

Responsibilities:Commissioning & Validation:Write and execute commissioning, qualification, and validation protocols for facilities, utilities, equipment, and computerized systems.Write final reports detailing the results of validation activities.Resolve protocol discrepancies and deviations by implementing corrective actions.Review vendor-generated validation protocol packages to ensure compliance with standards.Documentation & Reporting:Generate complex protocols using a risk-based approach that adheres to current regulatory requirements and industry practices.Maintain detailed and accurate documentation throughout the validation process.Collaboration & Communication:Collaborate with cross-functional teams to ensure the validation of all relevant systems and equipment.Maintain excellent communication with both internal stakeholders and external vendors to ensure smooth execution of validation tasks.Regulatory Compliance:Ensure that all validation activities align with FDA, cGMP, and industry standards.Support audits and inspections, providing validation documentation as needed.Skills and Qualifications:Education:Bachelor's degree (BScBEng) in Engineering or a related field. Relevant industry experience can be considered in lieu of formal education.Experience:5+ years of experience in commissioning, qualification, and validation within the Medical device industry.Extensive experience in areas such as plant utilities, clean utilities, CIP, SIP, HVAC, filling lines, CTUs, component prep equipment, and formulation.Proven experience writing and executing complex validation protocols.Technical Skills:Strong knowledge of the regulatory requirements and standards in pharmaceuticalbiopharmaceutical validation.Proficient in the use of risk-based approaches in validation activities.Soft Skills:Excellent verbal and written communication skills.Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.Strong organizational skills and the ability to work independently and as part of a team.

Created: 2025-02-24