Senior C&Q Engineer: Strategic Lead in Regulated Automation

Pauwels Consulting; Geel; Sur place; EUR 110 000 - 160 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking an experienced C&Q leader to strategically steer commissioning and qualification activities for a regulated pharmaceutical production environment in Belgium. You will define C&Q strategy based on risk analyses, V-model, and industry guidelines, and oversee qualification documentation and turnover packages.

You will lead and coach a team of C&Q engineers, serve as the main point of contact for the client, QA, and external suppliers, and ensure on-time progression of

Qualifications

• 8+ years of experience in commissioning and qualification within the (bio)pharmaceutical sector or a highly regulated environment.
• Demonstrated project-level leadership by steering a C&Q scope or leading a technical team.
• Deep knowledge of validation methodologies such as GAMP 5, EU GMP Annex 15, ASTM E2500, data integrity, and CSV.

Responsabilités

• Define the C&Q strategy based on risk analyses, the V-model, and ASTM E2500 in collaboration with QA.
• Take final responsibility for qualification documentation and turnover packages within the project scope.
• Lead and coach a team of C&Q engineers on planning, priorities and quality.
• Act as the single point of contact for the client, QA and external suppliers for technical and strategic questions.
• Monitor commissioning and qualification progress to secure critical path systems.
• Develop internal C&Q standards by creating templates and integrating lessons learned into future project phases.

Connaissances

C&Q leadership

Project leadership

GAMP 5

EU GMP Annex 15

ASTM E2500

Data integrity

CSV

PLC automation

Siemens

Rockwell

SCADA

DeltaV

Dutch language

English language

Outils

Kneat

ValGenesis

Description du poste

Pauwels Consulting is seeking an experienced C&Q leader to strategically steer commissioning and qualification activities for a regulated pharmaceutical production environment in Belgium. You will define C&Q strategy based on risk analyses, V-model, and industry guidelines, and oversee qualification documentation and turnover packages.

You will lead and coach a team of C&Q engineers, serve as the main point of contact for the client, QA, and external suppliers, and ensure on-time progression of