Validation Analyst

工作内容

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.

Let’s look together at your first challenge with us!

Analyst Validation

Our client is looking for an analyst who will provide support to the Technical Operations team in Geel for the technical transfer of 4 process steps from their US site to the site in Geel.

This role will be based in Geel (Belgium) which is the largest chemical production site within our client’s network within this nice.

Scope of work:

The Process Tech Transfer & Validation Support role will deliver support to the Tech Transfer project team and to the validation team by:

• Following up on which PPQ studies need to be performed when, in close collaboration with the process validation engineer and the project team
• Setting up PPQ plans for new PPQ-studies
• Preserving the production feasibility and efficiency, the aspects of quality, safety, health, environment and cost for the execution of the protocol in collaboration with planning department, process engineer, production department, QA and QC
• Supporting the development of statistical or risk-based sampling plans
• Drawing up and issuing validation documents, interpreting test results and performing statistical evaluations on these results which lead to validated processes
• Execute technical writing activities for update of criticality analysis of process steps
• Converting process recipes into batch recipes in Dutch for the Geel site
• Delivering general project support for the Tech Transfer such as preparing & reporting meetings, coordinating follow-up of action lists

Who are you?

• Master Degree in Science, Process Technology or equivalent by experience
• Preferably 2-5 years experience in life sciences business and GMP environment
• Fluently in English and Dutch, spoken & written
• Expertise in Small Molecule API manufacturing processes
• Knowledge of the field of validation
• Project management, organizing, planning and coordination skills
• Strong mind-set and knowledge of Quality & Compliance / regulatory requirements (GMP) and EH&S: adheres to applicable cGxP’s and procedures and management systems, reports incidents and deviations
• Experience with our client’s systems, such as ELIMS, Trackwise and TruVAULT, is a plus
• Ability to manage complexity, strict deadlines and change
• Ability to interact at different levels of the organization
• Ability to work under pressure, handle conflicting interests, having a good sense of prioritization of assigned tasks goals and manage time accordingly
• High level of technical accuracy
• Completer finisher, that keeps overview while taking care of the details in technical writing support
• Customer and business focus
• Informs the hiring manager and can call on the manager for consultation, in case of problems with stakeholders, fundamental problems concerning (technical) feasibility, etc

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

Are you interested? Apply now with your cv!