Senior Validation Engineer – GMP, Sterilization & SUS

Pauwels Consulting; Puurs-Sint-Amands; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a validated professional to oversee product and project lifecycles within the technical services department. You will provide end-to-end validation support, manage quality investigations, and ensure compliant production and new product introductions.

The role emphasizes SUS qualification, cleaning and sterilization validation, and GMP documentation in a fast-paced pharmaceutical environment.

Qualifications

• Master’s degree in a life sciences field.
• 3+ years of validation project execution experience.
• Strong GMP background with risk assessment and deviation management.
• Expertise in cleaning validation, sterilization validation, and Single Use Systems.

Responsabilités

• Manage the introduction and qualification of Single Use Systems (SUS) materials and filters for new products.
• Lead cleaning validation activities, including determining validation approaches and executing tests in production.
• Execute sterilization validation projects across techniques such as autoclave, VHP, and SIP.
• Perform urgent quality investigations and conduct risk assessments to support site technical activities.
• Prepare and maintain GMP documentation and master batch records for project compliance.
• Implement technical changes and assess deviations related to manufacturing systems and materials.

Connaissances

Validation management

GMP knowledge

Risk assessment

Deviation management

Technical writing

Problem solving

Organizational skills

English communication

Formation

Master’s degree in Bio-engineering/Pharmacy/Biochemistry/Biotechnology

Description du poste

Pauwels Consulting is seeking a validated professional to oversee product and project lifecycles within the technical services department. You will provide end-to-end validation support, manage quality investigations, and ensure compliant production and new product introductions.

The role emphasizes SUS qualification, cleaning and sterilization validation, and GMP documentation in a fast-paced pharmaceutical environment.