Biopharma Process Engineer – Equipment & CQV Specialist

Evote; Toulouse; On-site; EUR 55,000 - 75,000; Full time

Job summary

Evotec in Toulouse, France, is seeking a Manufacturing Equipment Specialist to support operations and the lifecycle of manufacturing equipment. The role covers CQV activities, CAPA handling, and collaboration with maintenance planning to ensure reliable maintenance execution.

You will contribute to GMP documentation, SOP authoring, and resolution of equipment issues, from bench to commercial scale, while coordinating with cross-functional teams in English and French.

Qualifications

• Master or Engineer degree in engineering/biotech or related field.
• 3+ years of relevant experience in a similar role.
• Fluent in English and French (verbal and written).
• Knowledge of processing equipment and biotherapeutics manufacturing.
• Experience with equipment commissioning, qualification, and validation.
• Knowledge of cGMP requirements; commercial site experience is a plus.
• Technical support and troubleshooting for critical manufacturing operations.
• Hands-on experience with single-use flow path operations and disposable-based manufacturing.
• Operation of process control systems and development of automation recipes.
• Ability to organize, analyze/interpret and communicate data.
• Authoring GMP-compliant technical and quality documentation.
• Execute risk assessments using tools like FMEA.

Responsibilities

• Support Manufacturing Operations within a biopharmaceutical facility, applying expertise in process control and equipment management.
• Act as equipment owner for manufacturing, ensuring lifecycle management of equipment.
• Support investigations, CAPA and changes for process equipment topics.
• Support CQV activities (IOQ and PQ) with technical expertise on USP/DSP processes.
• Assist manufacturing in troubleshooting and improvement projects.
• Define and execute manufacturing equipment maintenance plans in alignment with Maintenance planners.
• Create and review technical documentation for manufacturing processes (SOPs, work procedures, batch reports).

Skills

Process control

Equipment management

CAPA/Changes

CQV support

Troubleshooting

Maintenance planning

Documentation GMP

cGMP knowledge

Single-use systems

Automation recipes

Data analysis

English & French bilingual

Education

Master or Engineer degree in engineering/biotech

Job description

Evotec in Toulouse, France, is seeking a Manufacturing Equipment Specialist to support operations and the lifecycle of manufacturing equipment. The role covers CQV activities, CAPA handling, and collaboration with maintenance planning to ensure reliable maintenance execution.

You will contribute to GMP documentation, SOP authoring, and resolution of equipment issues, from bench to commercial scale, while coordinating with cross-functional teams in English and French.