QA Validation Specialist (H/F) Valais, Suisse

International engineering and technology expertise group, Fortil operates an independent model and brings together more than 2,500 employees. With 30 agencies across 14 countries, Fortil cultivates entrepreneurial freedom and empowers its people to drive innovation and excellence.

Job Description

In Switzerland, in the Canton of Valais, we are looking for a QA Validation Specialist (M/F) to join our Life Sciences team.

The position is based onsite in Visp and involves supporting a major expansion project in mammalian cell culture and biologics manufacturing.

Main responsibilities

• Provide QA oversight of qualification and validation activities for GMP equipment, facilities and systems.

• Ensure that equipment and systems are maintained in a validated and qualified state throughout their lifecycle.

• Review and approve validation documentation, including:

• Validation plans

• IQ, OQ and PQ protocols

• Validation and qualification reports

• SOPs

• Deviations

• CAPAs

• Change controls

• Perform change control assessments related to GMP equipment, facilities and systems.

• Develop validation protocols based on approved validation plans, where applicable.

• Provide technical expertise for the qualification and validation of:

• Autoclaves

• Clean utilities

• Controlled storage rooms and equipment

• Temperature mapping activities

• Shipping processes

• Manufacturing equipment and automated systems

• Support activities within quality systems such as DMS, LIMS, Kneat and TrackWise.

• Work closely with Operations, Engineering, Quality and other project stakeholders.

• Participate in audits and regulatory inspections.

• Ensure compliance with EU GMP and US FDA requirements.

• Support continuous improvement initiatives within the validation and qualification organisation.

• Plan and manage assigned activities autonomously in a fast-paced project environment.

Your Profile

• Between 2 and 6 years of experience in qualification and validation within a GMP-regulated pharmaceutical, biotechnology or cell and gene therapy environment.

• Strong understanding of the CQV and validation lifecycle.

• Practical experience with IQ, OQ and PQ activities.

• Experience reviewing and approving validation protocols and reports.

• Experience with change controls, deviations and CAPAs.

• Good knowledge of cGMP regulations and Manufacturing Quality Assurance.

• Experience with GMP equipment, facilities, utilities or automated systems.

• Familiarity with EU GMP and US FDA requirements.

• Strong technical documentation and review skills.

• Fluent English, both written and spoken.

• Autonomous, structured and able to become operational rapidly.

• Comfortable working in a multicultural and cross-functional environment.

• Academic background in engineering, biotechnology, chemistry, biology, pharmacy or a related discipline is an advantage.

• German language skills are an advantage.

• Experience with mammalian cell culture, biologics manufacturing, Kneat, TrackWise, LIMS or DMS is an advantage.

Reasons to join us

At Fortil, we put practical measures in place to support your development and ensure a stimulating work environment:

• Tailored support for upskilling and career development.

• Exposure to international projects and mobility opportunities.

• The opportunity to become an associate and contribute to collective success.

• Commitment to community initiatives and association-driven projects.

• A policy supporting parenthood and work-life balance.

Fortil is committed to equal opportunities. All positions are open to people with disabilities, without distinction of gender, origin or sexual orientation.