6467 - Senior CSV Engineer / Senior Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

• →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

This role requires the ability to be on-site, full-time in Devens, MA.