Experience: 20+ years
About the Job About Aligned Automation At Aligned Automation, we live by our "Better Together" philosophy to build a better world. As a strategic service provider to Fortune 500 companies, we help digitize enterprise operations and drive impactful business strategies. Our purpose goes beyond projects—we strive to deliver meaningful, sustainable change that shapes a more optimistic and equitable future. Our culture is deeply rooted in our 4Cs—Care, Courage, Curiosity, and Collaboration—ensuring that each employee is empowered to grow, innovate, and thrive in an inclusive workplace. Role Overview We are seeking an experienced Senior CSV / CSA Lead to manage validation, compliance, and lifecycle governance of GxP-regulated computerized systems within a pharmaceutical manufacturing environment. The role requires deep expertise in Computer System Validation (CSV), Computer Software Assurance (CSA), Software Validation, Data Integrity, and end-to-end qualification activities including IQ/OQ/PQ. The successful candidate will lead validation activities across manufacturing, laboratory, automation, infrastructure, cloud, and enterprise applications while ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA guidance, and ALCOA+ principles. Key Responsibilities Lead end-to-end CSV and CSA lifecycle activities for GxP computerized systems. Develop risk-based validation and assurance strategies aligned with CSA and GAMP 5 methodologies. Author, review, and approve: Validation Plans URS / FS / DS documents Risk Assessments Traceability Matrices IQ/OQ/PQ Protocols Validation Summary Reports SOPs and Work Instructions Execute and oversee qualification activities including IQ, OQ, PQ, FAT, SAT, and commissioning support. Validate all categories of GxP applications including: Custom built Applications SaaS / Cloud Applications Infrastructure and Server Validation Automated Manufacturing Systems Serialization and Packaging Systems MES,LIMS,SCADA,ERP,QMS Historian Systems Laboratory Instruments Chromatography Systems Ensure compliance with: FDA 21 CFR Part 11 EU Annex 11 GAMP 5 CSA Guidance Data Integrity and ALCOA+ requirements Manage change controls, deviations, CAPAs, incidents, periodic reviews, and validation impact assessments. Support regulatory inspections, audits, and remediation activities. Collaborate with QA, IT, Engineering, Automation, Manufacturing, and external vendors. Mentor junior validation engineers and provide technical leadership across projects. Required Qualifications Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline. 8+ years of experience in CSV/CSA within pharmaceutical, biotech, or regulated manufacturing environments. Strong expertise in: Computer System Validation (CSV) Computer Software Assurance (CSA) Software Validation IQ/OQ/PQ Data Integrity GxP Compliance SDLC Validation Experience validating enterprise, manufacturing, laboratory, automation, cloud, and infrastructure systems. Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA, and Data Integrity regulations.
