QA Automation Engineer

These roles will support automation quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment, with a strong focus on commissioning, qualification, validation, and lifecycle documentation for automation systems. This is an excellent opportunity for candidates with pharmaceutical or biotech automation QA experience who are comfortable working cross-functionally with Validation, Engineering, Manufacturing, and Quality teams in support of large-scale capital and operational projects.

• Provide QA oversight and support for automation-related qualification and validation activities
• Review and approve validation lifecycle documentation including:
• IQ/OQ/PQ protocols and reports
• 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 to ensure compliant execution of project deliverables
• 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

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field preferred
• 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
• Excellent communication and cross-functional collaboration skills
• Ability to work independently in a remote environment