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.
- 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.
- 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.
- Bachelor’s degree or a University Certificate or Degree in Science, information systems, engineering or related field.