Project Engineer Validation & Site Tech

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

Our client, a leading pharmaceutical company, is seeking a professional to manage product and project lifecycles within their technical services department. The role focuses on providing end-to-end validation support and managing quality investigations to ensure seamless production and new product introductions.

• Manage the introduction and qualification of Single Use Systems (SUS) materials and filters for new products.
• Lead cleaning validation activities, including the determination of validation approaches and execution of tests in production.
• Execute sterilization validation projects across various 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.

• You have a Master’s degree in Bio-engineering, Pharmacy, Biochemistry, or Biotechnology.
• You bring 3+ years of experience in executing validation projects and coordinating technical planning.
• You possess a strong background in a GMP environment, specifically with risk assessment and deviation management.
• You have expertise in validation including cleaning validation, sterilization validation, and Single Use Systems.
• You're an organized, analytical, and proactive individual with strong technical writing and problem-solving abilities.
• You are fluent in Dutch with a good knowledge of English.

Nice to Haves

• Experience designing and maintaining master batch records.
• Willingness to work in a shift system for specific project requirements.