Dynavax Technologies

Senior Specialist Computer System Validation m,f

DE-NW-Düsseldorf
3 weeks ago
Req. #
HP-215
# of Openings
1
Category
Quality Assurance

PRIMARY PURPOSE OF POSITION

In this role you will be responsible for carrying out Installation, Operational and Performance Qualification of new and modified computerized systems and equipment in order to demonstrate that the system is fit for its intended use, and meets critical requirements.

MAJOR DUTIES OF POSITION

  • Coordination and execution of computerized system validation activities for diverse equipment and systems, including but not limited to QC instrumentation, manufacturing equipment, and direct impact software systems.
  • Generation of validation protocols and reports
  • Follow and apply the Life Cycle approach according to GAMP for computerized systems (e.g. creation of Functional and Design Specifications, Risk Assessments, IQ / OQ / PQs, annual reviews)
  • Working successfully with diverse international and cross functional stakeholders to drive validation projects and deliverables
  • Compliance with site SOPs and regulatory guidelines
  • Oversight of external vendors supporting validation activities
  • Proactive, constructive collaboration with stakeholders from QA, QC, Plant Engineering, and Manufacturing departments to achieve site goals

KNOWLEDGE AND SKILL REQUIREMENTS

  • Degree in a science related discipline
  • Strong CSV background
  • GMP experience in a pharmaceutical/biopharmaceutical manufacturing environment
  • Organizational planning and ability to handle multiple projects at the same time
  • Timeline driven
  • Proactive and motivated team player
  • Working knowledge of German and English languages
  • Excellent communication skills

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