Responsibilities

Execute and support the full computer system validation lifecycle, including planning, testing, implementation, and periodic review activities.
Develop, review, and maintain validation documentation such as Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
Collaborate with Quality, IT, Engineering, and Operations teams to ensure systems comply with GxP, FDA 21 CFR Part 11, Annex 11, and company quality standards.
Lead validation activities for new system implementations, upgrades, and infrastructure changes across manufacturing, laboratory, and business systems.
Investigate and assess deviations, incidents, and change controls to determine validation impact and ensure continued compliance.
Support internal audits and regulatory inspections by providing validation documentation and subject matter expertise as required.

Requirements:

Experience with Computer System Validation (CSV) for manufacturing, laboratory, utility, or quality systems.
Validation of PLC, SCADA, HMI, and automated control systems.
Experience with data integrity assessments and Annex 11 / 21 CFR Part 11 compliance.
Experience supporting GMP inspections, audits, and CAPEX project delivery within regulated pharmaceutical environments. Required Experience & Qualifications
Degree or equivalent qualification in Engineering, Computer Science, Life Sciences, or a related technical discipline.
3-5 years' experience within a pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environment.
2-3 years' experience in Computer System Validation (CSV), Validation, Automation, or a related compliance-focused role.
Strong knowledge of GAMP 5, CSV lifecycle activities, cGMP requirements, and relevant regulatory expectations.
Experience generating and executing validation documentation including DQ, IQ, OQ, PQ, and validation reports. Experience with change control, deviation management, and maintaining validated systems throughout their lifecycle

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Responsibilities

Execute and support the full computer system validation lifecycle, including planning, testing, implementation, and periodic review activities.
Develop, review, and maintain validation documentation such as Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
Collaborate with Quality, IT, Engineering, and Operations teams to ensure systems comply with GxP, FDA 21 CFR Part 11, Annex 11, and company quality standards.
Lead validation activities for new system implementations, upgrades, and infrastructure changes across manufacturing, laboratory, and business systems.
Investigate and assess deviations, incidents, and change controls to determine validation impact and ensure continued compliance.
Support internal audits and regulatory inspections by providing validation documentation and subject matter expertise as required.

Requirements:

Experience with Computer System Validation (CSV) for manufacturing, laboratory, utility, or quality systems.
Validation of PLC, SCADA, HMI, and automated control systems.
Experience with data integrity assessments and Annex 11 / 21 CFR Part 11 compliance.
Experience supporting GMP inspections, audits, and CAPEX project delivery within regulated pharmaceutical environments. Required Experience & Qualifications
Degree or equivalent qualification in Engineering, Computer Science, Life Sciences, or a related technical discipline.
3-5 years' experience within a pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environment.
2-3 years' experience in Computer System Validation (CSV), Validation, Automation, or a related compliance-focused role.
Strong knowledge of GAMP 5, CSV lifecycle activities, cGMP requirements, and relevant regulatory expectations.
Experience generating and executing validation documentation including DQ, IQ, OQ, PQ, and validation reports. Experience with change control, deviation management, and maintaining validated systems throughout their lifecycle