6467 - Senior CSV Engineer / Senior Validation Engineer

Verista, Inc.•Devens, MA

15h•$80,465 - $131,685•Onsite

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: 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 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.

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.

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