Job Detail

When you are part of Thermo Fisher Scientific, you will do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

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 Alschwil please visit: www.fisherclinicalservices.com

Validation Engineer / Document Writer

Position summary

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.

Key responsibilities

• 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


• 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.


• Providing hand’s-on support for daily business to the whole Fisher Clinical Services Allschwil site


• Author/review validation/qualification documents.


• Participate in cross-functional improvement and process monitoring teams to mitigate unfavorable trends.


• Develop protocols for medium to large-scale validation projects using a risk-based approach that meets internal, external, client and as well as the current regulatory requirements.


• Work cross-functionally with QA, Engineering, Project Managers, Ops, Customer Services etc.


• Participate in site specific and global standardization and improvement projects as an SME (Subject Matter Expert)


• Represent the Engineering Department in internal, customer and regulatory audits when required.

Your background

• 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


• Articulate complex concepts and processes in writing


• Strong interpersonal, communication and customer service skills
  

What we offer

• Employment within an innovative, growth-oriented organization


• Outstanding career and development prospects


• Company pension scheme and other fringe benefits


• Exciting company culture, which stands for integrity, intensity, involvement and innovation

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission.

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, disability or any other legally protected status.

Interested?

We are looking forward to receive your application. Please refer to the above Job ID and include your salary expectations as well as your period of notice.