Senior CSA Analyst - Plasma Systems & Site Enablement / Senior CSV Engineer

Job Overview: We are seeking a Senior CSV/CSA Engineer to lead validation activities for standalone, computerized bioprocess equipment being installed in a single-use manufacturing facility. The equipment will utilize UNICORN, KlariFi and Lucullus software and will not be integrated with the site DeltaV system. The engineer will own or lead the computer-system validation lifecycle while coordinating with Process Engineering, CQV, Automation, Quality, IT, equipment vendors and system owners. Senior Validation Engineer Responsibilities: Develop and execute the CSV/CSA strategy for standalone GMP equipment systems Review equipment and software architecture, intended use and GxP impact Author or review validation plans, system assessments, risk assessments and supplier assessments Review URS, functional specifications, configuration specifications and design documentation Develop and execute risk-based test protocols Evaluate vendor FAT, SAT, IQ and OQ documentation for leveraged testing Test user access, roles, permissions and account administration Test audit trails, electronic records and electronic signatures Verify recipe, method and configuration controls Test alarms, events, reports, data capture and record retention Verify backup, restoration, archival, time synchronization and disaster-recovery controls Assess compliance with 21 CFR Part 11, EU Annex 11 and applicable data-integrity requirements Maintain requirements traceability and validation-documentation packages Manage discrepancies, deviations, corrective actions and validation-summary reporting Support change control, SOP development, training and system release

Bachelor’s degree in Engineering, Life Sciences, Computer Science or a related discipline Approximately seven or more years of CSV, CSA or computerized-equipment validation experience in a regulated life-sciences environment Hands-on experience validating standalone GMP manufacturing equipment Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5 and data-integrity principles Experience testing access security, audit trails, electronic signatures, recipes, reports and computerized records Ability to review functional specifications, configuration specifications and system architecture Strong protocol authoring, execution and deviation-management skills Ability to work independently with equipment vendors, engineers and Quality representatives Direct experience with UNICORN, KlariFi or Lucullus Experience with chromatography, tangential-flow filtration or bioreactor systems Experience validating PLC/HMI- or SCADA-controlled equipment Familiarity with Kneat or another electronic validation lifecycle system Experience supporting new-equipment installation and capital-project execution Best Regards, Ishika