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  • Location: Germany
  • Salary: Open to negotiations providing a very competitive package alongside salary
  • Job Type:Permanent

Posted 16 days ago

  • Sector: Clinical Operations
  • Contact: Cameron Turnbull
  • Contact Email: cameron.turnbull@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2022-06-16
  • Job Ref: V-47387

Our client is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies. They are currently partnered with many biotech clients based in Europe and are seeking a CSV Validation Engineer. You will help support compliance initiatives for their clients, including developing validation documentation and/or managing a team to develop deliverables incorporating client input. 
Primary Responsibilities
  • Develop system validation scripts based on software/hardware configuration for enterprise systems.
  • Work with client Subject Matter Experts to document user requirements.
  • Update application system User Requirements, Functional, and Design Specifications.
  • Develop and assess Risks based on systems and processes.
  • Develop Installation Qualifications based on Design.
  • Develop Operation Qualifications based on functional requirements.
  • Develop Performance Qualification scripts based on configuration.
  • Execute test scripts (manual or automated execution).
  • Ensure all project-related issues and deviations are recorded, approved and dispenses accordingly.
  • Route validation documentation.
  • Manage Tasks based on aggressive timelines.
  • Interact with customers at multiple sites.
  • Interact in a team environment, managing tasks and escalating issues as needed.
Additional Responsibilities
  • Act as backup for ongoing change monitoring and reporting to internal team members and Cloud Assurance customers.
  • Assist in authoring change assessments and reports based on established SOPs and templates.
  • Understand and describe how the change control process relates to the validated state of an application.
Qualifications
  • 4-5 years of experience with computer systems validation implementation.
  • Validation experience with computerized systems in the pharmaceutical industry.
  • Excellent oral and written communication skills in English. German and Spanish will be considered a plus.
  • Strong technical background – familiar with IT Infrastructure
  • Thorough understanding of the principles of computer systems validation and assurance, SDLC methodologies and testing best practice.
  • Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
  • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
  • Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
  • Ability to work independently with minimal supervision.
  • Excellent note taking and organizational skills for tracking changes and tasks from multiple sources.
  • Ability and willingness to take direction and learn from constructive feedback and errors, with the emphasis on continuous improvement.
  • Active learning style, including self-directed learning and query.
  • Systems thinker who can understand how parts of the process relate to the whole.
  • Ability and willingness to reach out to various SMEs for research, troubleshooting, and other assistance.
  • Experience communicating with customers.
  • Equipped to work remotely and willing to adapt to working with others in different time zones, when required.
  • Experience in Waterfall and Agile projects.
Education & Certifications
  • Bachelor’s degree or a University Certificate or Degree in  Science, information systems, engineering or related field.