Qualification Engineer

Direct message the job poster from X4 Life Sciences

Principal Contract Consultant: Quality, Validation & Regulatory - EU

Qualification Engineer

Role Type: Permanent

We are seeking a detail-oriented Qualification Engineer to join our client’s team in a documentation-focused role. This position is ideal for professionals passionate about ensuring compliance and quality through meticulous documentation, process validation, and equipment qualification.

As a Qualification Engineer, you will play a critical role in supporting the commissioning and qualification of equipment, facilities, and utilities in line with regulatory guidelines. Your work will help ensure product safety, efficacy, and quality across the client’s manufacturing and development operations.

Key Responsibilities:

• Prepare, review, and execute qualification protocols (IQ, OQ, PQ) for equipment, systems, and utilities.
• Author and maintain comprehensive documentation.
• Support qualification activities for new and existing systems.
• Collaborate cross-functionally with Quality Assurance, Engineering, and Manufacturing teams to ensure timely and compliant project execution.
• Assist with regulatory inspections and audits by providing accurate and complete documentation.
• Ensure all qualification activities are conducted in compliance with the relevant standards.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3 years + experience in qualification within the pharmaceutical, biotech, or medical device industry.
• Strong understanding of GMP guidelines and industry best practices.
• Exceptional attention to detail with a passion for documentation and compliance.
• Strong organizational and communication skills.
• Fluent German.

What the client offers:

• A documentation-driven role in a high-impact, compliance-focused environment.
• A clearly defined career path with multiple methods for advancement.
• Opportunities to grow into Team Leader, Project Lead, or Specialist roles based on your interests and performance.
• Supportive work culture with professional development programs, mentoring, and ongoing training.

Please note, we have a range of positions for Qualification / CQV Engineers across Switzerland and the EU, so if the type of role posted above is interesting to you but for a different location, then still do apply!

Also, our current roles do not provide sponsorships at the moment so a right to work is essential.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Consulting and Engineering
• Pharmaceutical Manufacturing