Job Description:

Job Duties:Ready to make your application Please do read through the description at least once before clicking on Apply.Manage start-up, commissioning, qualification, validation, and revalidation projects for various processes including facility, equipment, critical utility, automation/computer systems, cleaning, sterilization, medical devices, and drug product manufacturing.Oversee the delivery of validation in complex, capital projects, ensuring adherence to engineering, quality, and compliance standards.Create, execute, and summarize qualification and validation protocols.Perform risk and impact assessments, defining system boundaries.Ensure protocols, records, and procedures meet current Good Manufacturing Practices (cGMP), industry standards, and approved SOPs.Coordinate investigation and impact assessment for any deviated equipment or processes identified during calibration or validation.Provide validation input for quality systems such as CAPAs and change controls.Undertake other assigned duties and projects.Qualifications:Minimum 8-10 years of validation experience in pharmaceutical, medical device, or FDA-regulated environments.Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations.Ability to initiate, manage, and close quality systems such as change control, CAPA, and deviation management.Detailed experience performing root cause analysis investigations for deviations and non-conformances with a technical scope.Excellent written and verbal communication skills.Solid understanding of quality risk management principles and statistical concepts applicable to the area of responsibility.Subject matter expert on regulations and best practices pertaining to validation.Practical application and knowledge of ISO 13485, GHTF Process Validation Guidance, and other applicable standards used in medical device manufacturing.Education:Bachelor's degree in an engineering discipline.