Lead Qualification Engineer, Liestal

Duration: 6 months (with planned extension)

Role Overview For an on-site project in the Basel Area, we are currently seeking an experienced Monitoring Lead– Clean Utilities to support qualification and monitoring activities within a regulated GMP environment.

In this role, you will take the lead on monitoring and performance qualification activities for clean utility systems, ensuring compliance with regulatory expectations. You will act as a subject matter expert for purified water and process gas systems, drive risk-based approaches, and lead investigations related to deviations and monitoring outcomes.

Key Responsibilities

Lead Monitoring and Performance Qualification (PQ) activities for clean utilities, including purified water and process gas systems (e.g. nitrogen)

Perform and oversee risk assessments related to PQ and monitoring activities

Act as investigation lead, authoring high-quality investigation reports and driving root cause analyses

Present monitoring strategies, PQ approaches, and deviations to Swiss authorities when required

Collaborate closely with internal stakeholders to ensure compliant and robust utility operations

Required Experience&Qualifications

Solid experience in qualification and operation of purified water and process gas systems

At least 2 years of hands-on experience leading risk assessments for PQ activities

Minimum 2 years of experience defining and executing monitoring strategies for clean utilities, with a strong focus on Performance Qualification

At least 5 years of experience leading investigations and writing detailed, GMP-compliant investigation reports

Fluent German is mandatory (non-negotiable)

Confidence and willingness to interact with and present to Swiss regulatory authorities

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