Qualification Engineer

Position:
Commissioning Qualification & Validation Engineer

Location:

Lausanne

• Establish and execute qualification protocols; IQ, OQ, PQ
• Write technical documentation including equipment risk assessments (critical component assessments), Validation Plans, Requirement Tractability Matrices and qualification reports
• Participate in the qualification of systems such as HVAC, Clean Utilities, process equipment or lab equipment
• Manage associated qualification deviations & CAPAs, including opening, resolution (with Supplier) and closure
• Contribute to risk assessments and quality improvements

• Master’s degree in sciences or engineering or equivalent in experience.
• At least 4 years of experience in equipment qualification (IQ, OQ, PQ)
• Previous work experience in either the Pharmaceutical, Biotech or Medical Devices sector
• Good analytical, organizational, time management and problem-solving skills.
• Good writing skills. Able to develop and execute DQ, FAT, SAT, OQ, PQ, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines under direct or indirect supervision of the Senior engineering team.
• Solid knowledge of current FDA and EU regulations and best practices
• French with good knowledge of English

• Continuous learning and development opportunities via internal or external training and workshops
• Competitive salary package in line with industry practice together with exceptional employment benefits