Specialist II, Software Validation

Responsible for preparing and executing test documentation for computerized systems that affect regulatory compliance and non-regulatory processes based on MicroVention’s Quality Management System (QMS) procedures. Job duties:

• Assist the business or process owner to complete and seek approval for software change requests.
• Create or modify software requirement specifications to include applicable user/functional requirements for a system change.
• Write test scripts for testing scenarios and define test plans for execution.
• Develop software validation protocols (IQ, OQ, PQ) to verify if the system is compliant with regulatory and business requirements.
• Perform dry run or other testing processes with functional/technical resources to uncover issues before formal validation begins.
• Review and create validation reports to summarize results to include defects or issues during the test execution.
• Manage completion of projects per software validation master plans and ensure timely completion. Maintain frequent communication with stakeholders and managers regarding project status.
• Work with internal/external validation resources to guide them on company procedures and key business processes on the software being tested.
• Develop software validation procedure(s) as needed to ensure alignment with appropriate regulatory requirements. This includes, but is not limited to, SOPs, work instructions company forms, risk assessment procedures, change control documents, etc.
• Ensure software lifecycle program complies with applicable regulatory requirements including requirements for electronic records and electronic signatures.
• Review and approve software validation protocols and reports (e.g., verify that test cases are adequate, verify executed protocols for GDP, etc.)
• Demonstrate effective communication style working with all levels of organizational structure through multiple departments and across global sites.
• Provide software training to users within the organization after receiving training from the implementation vendors.
• Question current methods while evaluating continuous improvement on validation processes and procedures.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.