The Agile PLM 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, California
job type: Permanent
salary: $115,000 - 120,000 per year
work hours: 8am to 5pm
- 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 5 years of experience
- Education: Bachelors (required)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
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