6467 - Senior CSV Engineer / Senior Validation 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

Job Requirements:

• 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.