Quality Operations Engineer – CSV

Agap2 is a European engineering and operational consulting group founded in 2005 specialising in industry. We work in the pharmaceutical, biotechnology, medical devices, watchmaking and precision mechanics sectors.

As a consultant, you will be required to support our clients in the execution of their projects on site by providing your expertise and skills. You are agile and eager to adapt to different working environments that will fuel your curiosity to see what lies behind the closed doors of the largest projects in our clients’ portfolios.

Your missions

• Be a Quality reference for operational teams and support daily activities.
• Manage and/or contribute to the handling of deviations, CAPA, Change Controls and investigations.
• Take charge of or participate in Computer System Validation activities: strategy, risk analysis, URS, protocols, validation reports, etc.
• Ensure the maintenance of the validated state of GxP computerised systems.
• Collaborate with Quality, IT, Engineering, Operations and Manufacturing teams on cross-functional projects.
• Participate in audits, inspections and inspection readiness activities.
• Identify improvement opportunities and contribute to the evolution of Quality Systems.

Profile sought

• 5 to 10 years of experience in Quality Assurance, Quality Operations or Quality Engineering in a pharma, biotech or biopharma environment.
• Practical experience in GMP/GxP and Computer System Validation (CSV).
• Good mastery of Deviation, CAPA, Change Control and Risk Management processes.
• Master’s degree or equivalent in science, engineering, pharmacy, biotechnology, IT or a similar field.
• Fluent English.