Senior Computerized Systems Validation Engineer (m/w/d)

Job title: Senior Computerized Systems Validation Engineer (m/w/d)
Contract Type: Contract
Location: Konstanz, Germany
Salary: Competitive
Reference: BH-126367
Contact Name: David Cabrera
Phone Number: +49 621-3999-8220
Job Published: 11 days ago

Job Description

Your task:
  • Ability to perform the following with limited guidance
  1. Validation Planning
  2. System Assessments GxP, ERES, Annex 11, Data Integrity
  3. Functional Risk Assessments
  4. Chair Design Review
  5. Prepare RTMs
  6. Prepare IQ, OQ  & PQ Protocols & Reports
  7. Validation Reports
  8. CAPA Managemen
  • Dealing  with Data Integrity issues including Centralized User Access, Audit Trails
  • Manage and work with equipment vendors and system integrators
  • Interact effectively with stakeholders – Engineering, Qualification, IT, QA, Users
Your profile:

Essential Attributes
  • 10+ years Life Sciences experience in CSV in Life Sciences
  • Significant experience (+5 years) with CSV of Fill Finish equipment
  • Significant experience with Siemens S7, WinCC & Profinet
  • Significant experience with GAMP 5 SDLC
  • Significant with automation system migrations
  • Good knowledge of regulatory standard CFR Parts 210, 211 and Part 11
  • Fluent in English and able to understand communicate in German, excellent written English
Desirable Attributes
  • Experience with Interfacing with Werum PAS-X
  • Experience with interfacing with Aspentech IP 21 and/or OSI PI Historians
  • Experience with Virtualized Infrastructure, (VMs, VLANs)
  • OPC – UA including XML, PackML

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