Launch Excellence Project Engineer - Validation

Pauwels Consulting; Puurs-Sint-Amands; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Pauwels Consulting in Belgium seeks an experienced Validation Specialist to lead GMP validation for new product introductions. The role covers documenting processes, risk assessments, and cross-functional collaboration to ensure regulatory compliance and successful implementation.

You will coordinate validation activities, manage investigations, and drive process improvements with a strong emphasis on quality and timelines. Fluent Dutch and good English are required.

Qualifications

• Master's degree in a relevant scientific field.
• 3+ years in a GMP environment with validation and risk assessment focus.
• Strong planning and project coordination for complex validation projects.
• Analytical, technical writing and problem-solving with a quality mindset.
• Proactive team player who can work independently or with others.
• Fluent in Dutch with good knowledge of English.

Responsabilités

• Validate and document processes for formulation, filling, shipping, and packaging.
• Execute and document urgent quality investigations.
• Perform comprehensive risk assessments and define mitigation measures.
• Support and implement process and system changes for product introductions.
• Provide overall project management, including coordination, planning, and progress reporting.
• Collaborate with cross-functional teams to ensure service standards and goals.

Connaissances

GMP validation

Risk assessment

Project coordination

Technical writing

Analytical skills

Dutch language

English language

Team player

Formation

Master's degree in Bio-engineering / Pharmacy / Biochemistry / Biotechnology or related field

Description du poste

Our client, a leading pharmaceutical organization, is looking for a professional to manage validation aspects for new product introductions. The role oversees a broad range of activities to ensure successful implementation and regulatory compliance throughout the product lifecycle.

• Validate and document processes for formulation, filling, shipping, and packaging.
• Execute and document urgent quality investigations.
• Perform comprehensive risk assessments and define appropriate mitigation measures.
• Support and implement process and system changes related to product introduction.
• Provide overall project management, including coordination, planning, and progress reporting.
• Collaborate with cross-functional teams to ensure adherence to service standards and organizational goals.

• Master's degree in Bio-engineering, Pharmacy, Biochemistry, Biotechnology, or a related scientific field.
• You have 3+ years of relevant experience in a GMP environment focusing on validation and risk assessment.
• You bring proficiency in planning and project coordination for complex validation projects.
• You possess strong analytical, technical writing, and problem-solving skills with a quality-conscious mindset.
• You're a proactive team player who can work both independently and collaboratively.
• You are fluent in Dutch with a good knowledge of English.

Nice to Haves

• Previous experience delivering medior-level operational services.
• Willingness to work in shifts for specific project requirements.