Quality Control Validation Engineer (F/H)

Reposted 10 Days Ago
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Aubagne, Bouches-du-Rhône, Provence-Alpes-Côte d'Azur
In-Office
Senior level
Biotech
The Role
The Quality Control Validation Engineer ensures product sterility by implementing validation methods, managing validation processes, providing training, drafting SOPs, and supporting audits in the pharmaceutical or medical device industry.
Summary Generated by Built In
As a Quality Control Validation Engineer (F/H), you will be responsible for ensuring the sterility of products by utilizing core skills and a strong technical knowledge of appropriate standards, procedures, methods, and techniques, as well as current good manufacturing practices and state-of-the-art practices. In this role, you will support the implementation, maintenance, and improvement of this process at overseas manufacturing sites.

Grow with us - Your Responsibilities

  • Implement and optimize sterility validation and testing method according to the established validation plan and strategy.

  • Establish a plan and coordinate the project at the local site based on the global process.

  • Support the maintenance of validation as described in the validation plan and procedures.

  • Provide training at local manufacturing sites.

  • Draft and revise Standard Operating Procedures (SOPs).

  • Support customer audits and inspections.

  • Support continuous process improvement efforts.

  • Provide support for new internal and sponsored projects, including reviewing protocols and reports.

  • Provide support in managing Out of Specification (OOS) issues.

  • Collaborate with staff to address and resolve deviations and incidents.

  • Follow up on corrective and preventive actions resulting from deviations and audit observations.
     

What will convince us

  • Bachelor's degree in microbiology, biotechnological engineering, or a related field.

  • 5 years of relevant professional experience, including more than 2 years in the pharmaceutical or medical device environment.

  • Knowledge of relevant industry standards and practices with a demonstrated ability to interpret these regulations to ensure proper implementation in quality systems.

  • Good knowledge/experience in the pharmaceutical/medical device industry/laboratory good practices.

  • Ability to quickly acquire organizational skills, including the ability to effectively manage multiple processes and priorities, assess the requirements of assigned tasks cross-functionally, identify potential challenges, and communicate effectively to expedite the successful execution of assigned work.

  • Be a proactive force in strategic approaches.

  • Project management experience with different cultures.

  • Full proficiency in English.

About Sartorius 

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. 

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. 
www.sartorius.com/careers

Top Skills

Good Manufacturing Practices (Gmp)
Standard Operating Procedures (Sops)
Sterility Validation
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The Company
HQ: Göttingen
9,059 Employees
Year Founded: 1870

What We Do

Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing.

We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide.

With innovative laboratory instruments and consumables, the our Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes.

The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically.

Based in Göttingen, Germany, Sartorius also has a strong global reach with around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies.

In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe.

Join our team, partner or collaborate with us.

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