Vacancy caducado!
job summary:The Software Validation Engineer will provide CSV/Assurance support for computerized systems, networks and software that have been newly installed, upgraded and/or modified to support cGMP functions in Manufacturing, Supply Chain, and Quality. They will work closely with Validation Change Owners to generate and execute validation documents (IQ, OQ, IOQ, PQ etc.) that are compliant with Corporate and Plant policies and procedures. location: San Clemente, Californiajob type: Permanentsalary: $125,000 - 130,000 per yearwork hours: 8am to 4pmeducation: Bachelors responsibilities:
- Initiates, leads and authors CSA risk assessment, gap analysis, and deviation management associated with validation programs with precise document writing following Good Documentation Practices (GDocP) with clarity to meet the set forth expectations.
- Ensure Assurance/Validation deliverables contain all relevant information, rationales, references, and data to support the change and that all reports and protocols are reviewed and approved as appropriate.
- Ensure Assurance Plans and strategies are in alignment with IT policies, procedures and guidelines and external regulatory requirements, and European and International standards.
- Interact with QA, IT, Engineering and BPOs to understand functionality and use of automated control systems.
- Review and provide feedback to plant and corporate policy authors on CSV guidelines, specifications and policies.
- Coordinate tasks with validation technician(s) and validation consultants to provide project and technical direction, as needed.
- Plan, lead and execute lead assurance testing and revalidation of computer systems.
- Participate on investigation teams in the event of adverse validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring validation expertise and strong analytical and systematic problem solving skills.
- Experience level: Experienced
- Minimum 8 years of experience
- Education: Bachelors (required)
- Oracle EBS (3 years of experience is required)
- Test Automation (3 years of experience is required)
- Software Quality Assurance (8 years of experience is required)
- Validation