QA CSV Engineer (m/w/d)

Join a Leading Force in Life Sciences

Become an integral part of an established company with over 25 years of experience in the Swiss industrial ecosystem. Our team at Techfirm Engineering fosters a multicultural and collaborative environment, promoting respect and inclusivity. We are dedicated to ensuring that our consultants, clients, and project teams work closely together to achieve remarkable outcomes.

Your Mission

In this role, you will be instrumental in supporting and ensuring the quality and compliance of computerized systems within a GMP-regulated environment. Your collaboration with various functions including Quality Assurance, IT, Engineering, and Manufacturing will be vital to meeting the highest standards in the Life Sciences sector.

Key Responsibilities

• Plan, coordinate, and execute Computer System Validation (CSV) activities within a GMP-regulated setting.
• Support the validation lifecycle of GxP-relevant computerized systems.
• Prepare, review, and maintain essential validation documentation.
• Support and execute IQ/OQ/PQ testing and User Acceptance Testing.
• Ensure compliance with data integrity principles throughout the system lifecycle.
• Assist in managing deviations, change controls, and CAPAs related to computerized systems.
• Collaborate with cross-functional teams and support audit preparations.
• Contribute to the enhancement of CSV processes and quality systems.

Your Profile

• A degree or professional qualification in Engineering, Life Sciences, Computer Science, Information Technology, or a related field.
• 3-5 years of experience in Computer System Validation (CSV).
• Strong knowledge of GMP/GxP requirements and practical experience with validation documentation.
• Understanding of Data Integrity and ALCOA+ principles.
• Excellent communication and collaboration skills, able to work independently and as part of a multidisciplinary team.
• Fluency in English is essential; German is an advantage.

What We Offer

At Techfirm Engineering, you can expect:

• A strong focus on well-being and professional growth.
• High-impact projects that align with your skills and career aspirations.
• An environment that promotes diversity and equal opportunities.

Join us in shaping the future of Life Sciences and make a meaningful impact in your field. Be part of a team that values innovation, collaboration, and excellence.