Our client is a leader in infectious diagnostic solutions. The Software Validation Engineer will be part of a remediation project contributing towards the company’s dedication to producing effective, high quality products that meet and exceed FDA standards.
Responsibilities:
- Become the subject matter expert on computer system lifecycle, electronic records and governing FDA regulations.
- Ensure software and electronic records meet FDA requirements
- Implements best practices to improve data integrity, management and retention.
- Collaborate with engineering, laboratory and business units to ensure software and processes comply with quality and regulatory requirements.
- Collaborate with teams to develop and certify data documents to FDA regulations and company standards
- Pilot new processes and procedures
- Collaborate with all business units to develop and enforce SOP’s governing software, documents and data
Qualifications/Education
- Bachelor’s degree or similar work experience working with data in a highly regulated environment.
- Experience working with cross functionally with non-technical groups
- Database experience
- Experience performing risk assessments, requirements gathering and delivering a finished product
- Project Management experience, preferred.