Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Computer System Validation Engineer

Bothell, WA, US • Posted 17 days ago • Updated 1 hour ago
Full Time
On-site
Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

  • Test Execution
  • Testing
  • Collaboration
  • Teamwork
  • Customer Focus
  • Communication
  • Good Manufacturing Practice
  • GxP
  • Software Development Methodology
  • Pharmaceutics
  • Manufacturing
  • IT Service Management
  • ServiceNow
  • Quality Management
  • Veeva
  • Conflict Resolution
  • Problem Solving
  • Enterprise Resource Planning
  • SAP
  • Oracle
  • Life Sciences
  • Industry-specific
  • Management
  • GAMP
  • Manufacturing Execution System
  • MES
  • Computerized System Validation
  • Documentation
  • Test Scripts
  • IQ
  • OQ
  • PQ

Summary

Summary:
  • The Computer Systems Validation (CSV) works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
  • This role is an individual contributor.
  • The CSV will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle.
  • The CSV has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant Client procedures and regulations.
Roles & Responsibilities:
  • uthor, review and / or approve applicable CSV documentation.
  • ssist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures.
  • ssist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
  • Other related duties as assigned.
Education & Experience:
  • bility to effectively communicate with both technical and non-technical team members.
  • Strong interpersonal skills, especially regarding teamwork, client focus, verbal and written communication.
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
  • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
  • Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).
  • Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
  • Strong technical and problem-solving skills and the ability to work independently.
  • Demonstrated success working in a high-performing, business results-driven environment.
  • Understanding of computer system validation.
  • Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
  • Understanding of Computer System Validation (CSV).
  • Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures.
  • Strong knowledge on Manufacturing Execution System (MES) validation.
  • Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures.
  • Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: deb9eaed6533a3c7fc695814ed76d111
  • Posted 17 days ago
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