Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.
We are looking for a Senior Quality Engineer to support our client operations by leading and executing various validation and qualification activities. This role plays an important part in ensuring equipment, facilities, utilities, and cleaning processes meet required quality and compliance standards. You'll collaborate across teams, contribute to strategic planning, and support ongoing improvement efforts within a regulated environment.
Key Responsibilities
* Develop and implement strategies for Fill & Finish equipment, utilities, and cleaning validation.
* Write, review, and execute qualification and validation protocols and reports (e.g., DQ, IQ, OQ, PQ).
* Collaborate with cross-functional teams to deliver validation projects on time.
* Mentor and support junior team members in validation activities and quality systems.
* Investigate and document deviations or issues related to validation studies.
* Recommend process improvements based on validation outcomes.
* Support audits, inspections, and routine quality system activities.
* Maintain documentation in compliance with industry regulations and internal procedures.
* Plan and coordinate periodic re-qualification and re-validation work.
* Promote adherence to quality and safety standards across operations.
Qualifications
* Bachelor’s or master’s degree in a science or engineering field (e.g., chemistry, biology, biochemistry, chemical engineering).
* 5+ years of experience in a regulated environment (such as pharmaceutical, biotech, or medical devices), with hands‑on experience in validation and qualification activities.
* Strong understanding of cGMP practices and validation principles.
* Experience working with critical systems and manufacturing equipment especially for Fill & Finish lines.
* Ability to write clear, concise technical documentation and handle investigations.
* Experience with root cause analysis and continuous improvement methodologies is an asset.
* Strong knowledge of global regulatory standards especially GMP Annex 1 (e.g., FDA, EU GMP, ICH guidelines).
* Languages: Fluent in German and English;
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