Qualification and Validation Engineer

Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.

Your work is crucial to the success of these projects.

Responsibilities

• As a Qualification and Validation Engineer you are responsible for developing, implementing, and executing qualification and validation activities for small-scale equipment in QC and Manufacturing, including related software, within a cGMP environment.
• You develop, implement, and execute URS, CAT, SIA, DQ, IQ, OQ, PQ, RV, and TM activities, including hands-on execution where required.
• You perform validation studies for cGMP-critical process systems to demonstrate compliance with user, regulatory, and cGMP requirements.
• You qualify systems where industry standards require case-specific interpretation, ensuring alignment with cGMP and cGLP requirements.
• You ensure that the qualified status of systems remains compliant with cGMP requirements at all times.
• You support project activities in accordance with applicable regulatory standards and internal procedures.
• You maintain up-to-date knowledge of validation regulations and best practices and provide technical input on US FDA and EU validation requirements.
• You take ownership of validation documentation through review, approval, and implementation.
• You assess changes and provide input on their impact on qualified status and validation documentation.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or a related scientific/technical field.
• Knowledge of cGMP requirements in a regulated manufacturing environment.
• 2–4 years of experience in a healthcare manufacturing environment, including qualification of small-scale equipment and related software.
• Understanding of applicable quality and compliance regulations.
• Experience with quality management systems.
• Ability to troubleshoot validation and qualification issues.

At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.

Together we make sure you get the most out of your career.