QA Validation Specialist (Fixed-Term Contract) We are seeking an experienced QA Validation Specialist to support a major biologics manufacturing expansion project in canton Valais. You will play a key role in ensuring GMP equipment, facilities, and systems remain qualified, validated, and inspection-ready throughout the project lifecycle.

This is a hands-on role requiring strong expertise in validation, qualification, change control, and GMP documentation review. The successful candidate will be able to quickly integrate into a fast-paced project environment and provide immediate value.

Key Responsibilities

Provide QA oversight of equipment, facility, and utility qualification and validation activities.
Review and approve validation protocols, reports, SOPs, deviations, CAPAs, and change controls.
Assess the impact of changes to GMP systems and ensure appropriate validation activities are completed.
Ensure systems remain in a validated state and comply with EU GMP and FDA requirements.
Support qualification activities including:
- IQ, OQ, and PQ
- Autoclaves
- Clean Utilities
- Shipping Validation
- Temperature Mapping
Develop validation protocols from approved validation plans when required.
Use and maintain quality systems including TrackWise, Kneat, DMS, and LIMS.
Support internal audits, regulatory inspections, and continuous improvement initiatives.

Requirements

2-6 years' experience in Validation, Qualification, CQV, or QA Validation within a GMP-regulated pharmaceutical, biotech, biologics, or cell & gene therapy environment.
Strong knowledge of IQ, OQ, PQ, validation lifecycle management, and maintaining a validated state.
Experience reviewing and approving GMP documentation, including:
- SOPs
- Validation protocols and reports
- Deviations
- CAPAs
- Change Controls
Working knowledge of EU GMP and FDA regulations.
Fluent English; German is an advantage.
Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or related discipline preferred, though equivalent industry experience will also be considered.

Candidate Profile

Able to hit the ground running in a critical project phase.
Comfortable working independently and managing priorities.
Strong attention to detail and quality mindset.
Effective communicator with the ability to work across Engineering, Operations, Quality, and external stakeholders.
Thrives in a collaborative and multicultural environment.

By applying for this role, you consent to SGI contacting you by telephone regarding recruitment services, market updates, and relevant business opportunities

We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.
Source Group International Ltd is acting as an Employment Business in relation to this vacancy

QA Validation Specialist (Fixed-Term Contract)

Job Description

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