Sr. Computer System Validation Specialist
management recruiters of edisonSpokane (WA)
Sr. Computer System Validation Specialist
Posted 2 days ago
management recruiters of edisonSpokane (WA)
SENIORITY
Senior
About the role
Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.
Job Description:
Responsible for the computerized system validation and data integrity at the plant site. The job functions include periodic review and audit trail reviews. Drafting, reviewing, and executing equipment-specific test plans. Drafting and reviewing user requirement specifications, risk assessments, traceability matrix, and qualification protocols – including test plans and acceptance reports. This person ensures the site’s data integrity strategy is sound and incoming systems are appropriately qualified and requalified to meet 21CFR and EMA Annex 11 requirements. Perform Periodic Reviews and Audit Trail Reviews of computerized systems. Write and review documents to support the qualification of a computerized system. Validation Plan User Requirements Specification Risk Assessment Traceability Matrix Qualification Protocol Qualification Test Plan Qualification Acceptance Report Validation Plan Acceptance Report Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary. Write and review CSV SOPs. Partner with other departments to ensure the site is compliant. Provide support for computerized systems and data integrity strategy during audits, deviations, and investigations.
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.