Validation Engineer (m/f/d)

☞ Thermo Fisher Scientific

View: 148

Update day: 25-04-2024

Location: Basel Basel-Stadt BS

Category: Quality Assurance / Quality Control

Industry: Biotechnology Research Pharmaceutical Manufacturing

Job type: Full-time

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Job content

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. Fisher Clinical Services GmbH is part of Thermo Fisher Scientific Corporation, a world-class company serving the scientific community and healthcare industry. We are leaders in providing clinical supply chain management services and clinical supplies distributed to patients worldwide. For more information about our site in Allschwil please visit: www.fisherclinicalservices.com. We are currently looking for aValidation Engineer (m/f/d)The Validation Engineer / Document Writer acts as the primary contact for Qual & Val activities and compliance within the Engineering Department.He / She supports the successful achievement of organizational department goals, and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of specific milestones associated with projects impacting cross-functional teams, supports various Department on diverse projects that extend beyond their functional area, and may provide project management leadership on tasks of moderate scope specific to their functional area. Using analytical skills and expertise, the incumbent independently identifies and solves challenges. The individual works collaboratively with their immediate supervisor, team members and internal and external customers to achieve team goals and uses informal leadership opportunities and effective communication to influence team direction and continue to build trust and value for CTD (Clinical Trial Division).Your tasks:
  • Writing and executing, and commissioning validation and qualifications protocols that challenge the critical parameters related to installation, operation, and performance of the related systems as per GxP regulations and internal procedures & policies
  • Preparing and executing periodical tasks such as Re-Assessments, Re-Qualifications, Re-Mappings and reviews as per GxP regulations and internal procedures & policies
  • Plans and carries out documentation for actions and follow-ups (corrective and preventive actions) on behalf of Dept. Head together with FM team on any incidents and none-compliance
  • Initiating change control, tracking and follow-up on activities (audit observations, CAPAs) applicable for general operational equipment, processes, etc.
  • Support Engineering and Qual / Val in documentation aspects for projects and daily business as necessary.
  • Demonstrate aptitude to analyze existing workflows, processes, supporting systems and procedures, and identify improvements.
Your profile:
  • Minimum of 2 years related experience in Validation / Qualification in the pharmaceutical sector overall
  • Familiar with the GAMP5 guidelines
  • Process Management
  • Current international regulatory regulations (GDP, EU GMP Chapter 4 – documentation, Annex 11 Computerized Systems, Annex 15, GAMP 5)
  • Excellent writing skills (English and German)
  • Open to innovative ideas and to question conventional thinking
  • Computer-savvy and well-versed in Microsoft Office products
  • GMP Data Governance - Principles for Data Integrity Assurance
  • Willingness to travel and work in different Fisher Clinical Services sites when required
At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. This job description does not describe all the duties, tasks and responsibilities which need to be performed in the Function. Any other job-related instructions, duties, tasks or responsibilities which are requested by the team leader or manager are required to follow.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Deadline: 09-06-2024

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