We are seeking a mid-level Computer System Validation (CSV) Engineer to support GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments.
This role is focused on hands-on execution of CSV lifecycle activities, working closely with Quality, Engineering, IT, and project teams to ensure compliance and timely delivery.
About the Role
We are seeking a mid-level Computer System Validation (CSV) Engineer to support GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments.
This role is focused on hands-on execution of CSV lifecycle activities, working closely with Quality, Engineering, IT, and project teams to ensure compliance and timely delivery.
Responsibilities
Execute CSV lifecycle activities for GMP computerized systems including MES, DCS, SCADA, and automated equipment
Prepare and support CSV documentation such as Validation Plans, URS, Risk Assessments, IQ, OQ, PQ, and final reports
Apply risk-based validation approaches for new and existing systems
Ensure compliance with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11
Support project teams to align validation activities with delivery timelines
Participate in validation risk assessments and define testing scope
Review system specifications, design documents, and qualification records
Support deviation management, discrepancy resolution, and data integrity assessments
Assist with periodic system reviews, audits, and regulatory inspections
Support development and maintenance of CSV and qualification SOPs
Collaborate with cross-functional and global CSV teams
Escalate quality or compliance risks where required
Follow EHS and site safety procedures during validation activities
Qualifications
Bachelor's degree in Engineering, Life Sciences, Computer Science, or related discipline
4–7 years' experience in Computer System Validation within pharma or biopharma
Strong understanding of CSV regulations and quality expectations
Hands-on experience validating GAMP Category 3, 4, and 5 systems
Experience executing validation protocols and managing validation documentation
Working knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines
Experience supporting investigations, root cause analysis, and CAPAs
Strong documentation and cross-functional collaboration skills
Required Skills
Strong understanding of CSV regulations and quality expectations
Hands-on experience validating GAMP Category 3, 4, and 5 systems
Experience executing validation protocols and managing validation documentation
Working knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines
Experience supporting investigations, root cause analysis, and CAPAs
Strong documentation and cross-functional collaboration skills
Preferred Skills
Experience in a GMP environment
Familiarity with EHS and site safety procedures
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