CQV Engineer m/f/d, Wallis

Coopers Group AG seeks a Mid-level CQV Engineer in Wallis, CH, to manage the full validation lifecycle for equipment, systems, and utilities within a GMP-regulated biotech environment.

This position focuses on managing the complete validation lifecycle within a dynamic biotech project setting. The successful candidate will apply their expertise in GMP-regulated environments to qualify and validate essential equipment, systems, and utilities, ensuring compliance and operational excellence.

Responsibilities

• Execute validation tasks covering facilities, utilities, and the entire validation lifecycle, including process execution, technical documentation, gap analysis, and risk assessment.
• Generate validation deliverables such as User Requirement Specifications (URS), Design Qualification (DQ), Failure Mode and Effects Analysis (FMEA), risk assessments, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and qualification protocols (IQ, IOQ, OQ, PQ).
• Draft validation documentation and carry out Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for various equipment, systems, and utilities.
• Compile reports summarizing completed validation activities.
• Identify opportunities to improve the efficiency of the validation program approach.
• Incorporate lessons learned and monitor industry regulatory updates related to equipment and facility validation.
• Manage quality system activities, including document management, change control, non-conformities, and corrective and preventive actions (CAPA).
• Draft and update procedures relevant to engineering operations.
• Assist the engineering team in developing validation, requalification, and maintenance programs.

Requirements

• Proven experience working in GMP-regulated environments.
• A strong passion for the qualification and validation of equipment, systems, and utilities.
• Capability to navigate the entire validation lifecycle.
• Excellent technical documentation skills.
• Knowledge of regulatory requirements specific to the biotech industry.

What the company offers

• Chance to contribute to high-impact engineering projects within the biotech sector.
• A supportive and professional work environment.
• Access to continuous professional development and training opportunities.

About the company

Coopers Group AG is a leading provider of specialized services in engineering, contracting, and talent acquisition. The company supports clients in the life sciences and technology sectors with expertise in regulatory affairs, quality management, and project execution. The team is committed to innovation, excellence, and client success.

• Leading provider of specialized services in engineering, contracting, and talent acquisition.
• Supports clients in the life sciences and technology sectors with expertise in regulatory affairs, quality management, and project execution.
• Committed to innovation, excellence, and client success.