IT Validation Leader in Hamburg bei Olympus Europa SE & Co KG

Your responsibilities

• Design, implement and manage all operational software validation activities within the Global IT organization
• Work closely with all Global IT functions to ensure the operation of validated environments (according to GMP and other regulatory requirements relevant to a MedTech company)
• Perform the initial Quality Gate Check when a new application / software is introduced to determine whether the software needs to be validated or not
• Provide guidance to Global IT teams on the process for the creation of validation documentation and requirements
• Ensure the development, review and approval of validation documentation including CSV/CSA Risk Assessments, change control forms, requirements, validation plans, data migration plans, IQ, OQ, PQ/UAT test protocols, test cases and reports, and requirements traceability matrices
• Provide expertise and advice to Global IT programs and projects on validation
• Support the revalidation process in the event of a major change
• Monitor the compliance of system adherence to good practice guidelines and regulations from creation of a medical device through to authorization to ISO standards (e.g., GMP, GCP, MDR etc.)
• Document compliance and progress towards the validation plan
• Review documentation for projects/ products and platforms to ensure governance is adhered to by the external and internal teams
• Manage spot check audits to ensure projects/ products/ platforms change governance is adhered to

Your qualification

• Bachelor’s degree in Life Science, Computer Science or Business (or equivalent and related experience preferred)
• At least 2 years in validation, preferably with a focus on pharmaceutical, biotechnology, clinical, medical, laboratory or other applicable area
• Experience in quality risk management and handling GxP regulations
• Experience in project management especially with regards to CSV/CSA
• Progressive experience in a multi-national, multi-divisional technology environment with demonstrated experience in planning, forecasting, modeling, and analysis
• Good understanding and application of FDA and regulatory requirements
• English and German language skills

Your benefits

• 30 days of annual leave
• Up to 60% mobile work possible + flexible work time model with overtime compensation
• Holiday and Christmas bonuses
• Corporate benefits discounts for employees
• Comprehensive company pension scheme and capital-forming benefits
• Company restaurant with live cooking and healthy food (subsidized)
• Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
• Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
• Various subsidized company sports groups and access to the inhouse company gym