Automation QA Engineer

New

ValspecPharmaceutical / Biotech

Support our clients in North CarolinaContractMiddle

Salary not disclosed

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Job Details

Experience: 3+ years

Requirements

Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field
3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industry
Strong understanding of GMP compliance and validation lifecycle principles
Experience reviewing and approving GMP documentation
Familiarity with data integrity and 21 CFR Part 11 requirements
Ability to work independently in a remote environment

Responsibilities

Provide QA oversight and support for automation-related qualification and validation activities
Review and approve validation lifecycle documentation (IQ/OQ/PQ protocols, reports, risk assessments, traceability matrices, change controls, deviations, and CAPAs)
Support automation systems operating within GMP manufacturing environments
Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements
Partner with Automation, CQV, CSV, Manufacturing, and Quality teams
Participate in document reviews, project meetings, and quality assessments
Support audit readiness and inspection preparedness activities
Assist with implementation and continuous improvement of validation and QA processes

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