Senior CSV Engineer

About the Role

We are seeking a Senior CSV/CSA Engineer to lead computerized system validation activities for standalone GMP bioprocess equipment in a single-use manufacturing facility. The role will support systems using UNICORN, KlariFi, and Lucullus and will work closely with Engineering, CQV, Automation, Quality, IT, equipment vendors, and system owners.

Responsibilities

• Lead CSV/CSA lifecycle activities for standalone GMP equipment.
• Develop validation plans, system assessments, risk assessments, and test protocols.
• Review URS, functional/configuration specifications, system architecture, and design documents.
• Review and leverage vendor FAT, SAT, IQ, and OQ documentation.
• Execute risk-based testing for access controls, audit trails, e-signatures, recipes, reports, alarms, and data integrity.
• Verify backup/restore, archival, record retention, and disaster-recovery controls.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and data-integrity requirements.
• Maintain traceability and validation documentation throughout the lifecycle.
• Manage deviations, discrepancies, CAPAs, change controls, and validation summary reports.
• Support SOP development, training, system release, and equipment installation activities.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field.
• 7+ years of CSV, CSA, or computerized equipment validation experience in a regulated life-sciences environment.
• Hands-on experience validating standalone GMP manufacturing equipment.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ / data integrity.
• Experience with PLC/HMI or SCADA-controlled equipment.
• Strong protocol writing, execution, deviation management, and risk assessment skills.

Qualifications

• Experience with UNICORN, KlariFi, or Lucullus preferred.
• Experience with chromatography, TFF, or bioreactor systems is preferred.
• Familiarity with Kneat or similar electronic validation systems.
• Experience supporting new equipment installation and capital projects.

Skills

• CSV/CSA
• Computerized System Validation
• GAMP 5
• 21 CFR Part 11
• EU Annex 11
• Data Integrity
• Risk-Based Validation
• GMP
• PLC/HMI
• SCADA
• UNICORN
• KlariFi
• Lucullus
• Kneat
• Validation Protocols