• Speak with authority on all things related to proper validation of systems (IQ/OQ/PQ) to FDA standards
• Independently test, demonstrate, inspect and/or analyze functionality of sponsor's tools, systems and applications to establish a clear understanding of delivered capability relative to user and system requirements.
• Manage a team of test IV&V engineers and their day-to-day activities
• Develop test processes and procedures
• Develop metrics, strategic activities, and de-conflicting requirements
• Determine the configurations needed for test setup and all Personal Software Product (PSP) overnight testing.
• Ensure network is operational, providing feedback to the customer and stakeholders, and recommending automation and/or processes to improve efficiency through increase performance and /or lower costs.
• Oversee performance testing and verification at both system and subsystem levels. Also included are functional testing, forensic analysis, PSP threat analysis, and validating ad hoc requests and requirements.
• Develop test plans and procedures, as well as the documentation recording the results of the IV&V to include a final report.
• Work with the customer to plan future IV&V needs, as required
• Bachelor's Degree required
This job operates in an office setting which incurs moderate noise consistent with a business office. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This is a largely sedentary role; however, some physical attributes are required, for instance, manual dexterity/typing, read, count and write to accurately complete all documentation, the ability to lift up to 25 lbs. as well as, ability to climb or balance, stoop, kneel, crouch or crawl.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required for this job. Duties, responsibilities and activities may change at any time with or without notice.