Validation Expert – Single-Use Systems

PQE Group; Osterreich; Remote; PEN 227,000 - 277,000; Full time

Job summary

PQE Group is seeking an experienced Validation Consultant – Single-Use Systems to drive end-to-end validation in a regulated pharmaceutical setting. The role is primarily remote with travel to Austria as needed for on-site work.

Responsibilities include developing validation strategies, creating comprehensive documentation, and ensuring regulatory compliance (USP/ISO/ASTM). Fluent English is required; German is a plus, with travel across the DACH region.

Qualifications

• Experience in pharmaceutical validation and qualification within regulated environments.
• Hands-on experience with Single-Use Systems (SUS).
• Experience leading teams and developing validation strategies.
• Fluent English; German is a plus; willingness to travel in the DACH region.

Responsibilities

• Develop and execute validation strategies for pharmaceutical single-use products/components.
• Create validation documentation including plans, protocols, traceability matrices, and final reports.
• Define qualification and testing requirements per regulatory standards (USP 665, ISO 11737, ISO 11137, ASTM D4169).
• Ensure traceability, compliance, and completeness of validation activities and deliverables.
• Review test results and identify risks and documentation gaps.
• Support on-site activities in Switzerland as required.

Skills

Team leadership

Independent work

Analytical skills

Documentation

Education

Engineering/Pharma/Chemistry degree

Job description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

We are looking for an experienced Validation Consultant – Single-Use Systems to support the end-to-end validation and qualification of a pharmaceutical single-use component or product within a regulated environment.

The initial contract duration will be 4–5 months and the position is primarily remote, although candidates must be available to travel to Austria and work on-site there whenever required by the project.

Responsibilities include:

• Develop and execute validation strategies for pharmaceutical single-use products/components.
• Create validation documentation, including plans, protocols, traceability matrices, and final reports.
• Define qualification and testing requirements in line with regulatory standards (USP 665, ISO 11737, ISO 11137, ASTM D4169).
• Ensure traceability, compliance, and completeness of validation activities and deliverables.
• Review test results and technical evidence, identify risks and documentation gaps.
• Support technical discussions and participate in on-site activities in Switzerland as required.

Requirements:

• Degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related field.
• Strong experience in pharmaceutical validation and qualification within regulated environments.
• Hands-on experience with Single-Use Systems (SUS).
• Good knowledge of USP 665, ISO 11737, ISO 11137, and ASTM D4169.
• Experience in leading teams.
• Proven track record in developing validation strategies and technical documentation from scratch.
• Experience with validation plans, protocols, traceability matrices, and final reports.
• Strong analytical, organizational, and documentation skills.Ability to work independently and meet deadlines.
• Fluent English required; German is a plus.
• Open to travelling in DACH region.
• Project start date: As soon as possible.
• Salary starts at €65.000 and can be higher depending on experience and qualifications.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration, innovation, and professional growth. PQE Group offers the opportunity to work on international projects, develop specialized expertise, and collaborate with industry-leading pharmaceutical companies worldwide.

If you are looking for a rewarding and exciting career in pharmaceutical compliance and quality, take the first step toward an amazing future with us.