Experience/Skillset Requirements
• Degree (Bachelors or Masters) in Computer/Electrical/Electronics Engineering or other relevant Field.
• At least 12+ years of experience in the Pharma industry with 6+ years of experience in a Validation Lead role preferably for a Europe based Pharma
• Hands-on experience with the validation of commercial, R&D and ERP and Corporate applications used for regulated activities in the pharmaceutical industry
• In depth knowledge of FDA/EMA guidelines relevant to 21 CFR Part 11, EU Annex 11 compliance requirements, medical device standards and Global Computer System Validation and ISPE GAMP guidelines
• Knowledge of Agile software development, and software testing methodologies.
• Excellent written and oral communication skills, good decision-making skills, and time management skills.
• Experience with cloud-based applications and/or infrastructure compliance