C&Q Engineer

Panda International; Beerse; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Panda International is seeking a C&Q Engineer to join our pharmaceutical project team in Beerse, Belgium. The role focuses on commissioning and qualification of equipment and systems within a GMP environment, ensuring validated state throughout the lifecycle and readiness for production.

You will collaborate with Engineering, Operations, Quality and Maintenance, drive QMS improvements, and mentor external C&Q engineers while maintaining strong regulatory alignment with Annex 1 and 21 CFR Part 11.

Qualifications

• Extensive experience in C&Q within a GMP environment.
• Strong knowledge of GMP regulations incl. Annex 1 and 21 CFR Part 11.
• Qualification of equipment, production systems, utilities and facilities.
• Ability to operate both strategically and hands-on in a pharma setting.
• Excellent communication and stakeholder engagement at all levels.
• Master's degree in Engineering, Science, or equivalent required.

Responsabilités

• Act as C&Q SME for equipment qualification activities.
• Develop, execute and maintain commissioning and qualification strategies.
• Ensure equipment remains validated and compliant throughout lifecycle.
• Collaborate with Engineering, Operations, Quality and Maintenance.
• Represent C&Q during regulatory and client quality audits.
• Communicate qualification strategy, progress and status to stakeholders.
• Drive QMS, C&Q process improvements and tool adoption.
• Mentor external C&Q engineers.

Connaissances

C&Q Engineering

GMP compliance

Annex 1

21 CFR Part 11

English communication

Dutch language

Formation

Master's degree in Engineering or related field

Description du poste

C&Q Engineer – Pharmaceutical Manufacturing – Belgium

Job Description

A leading global pharmaceutical organization is looking for an experienced Commissioning & Qualification (C&Q) Engineer to join their engineering team in Beerse, Belgium.

The role is part of a large-scale pharmaceutical manufacturing environment focused on ensuring that critical equipment and systems remain compliant, qualified, and ready to support the production of life-saving medicines.

As a C&Q Engineer, you will act as a subject matter expert for Equipment Commissioning & Qualification, working closely with Engineering, Operations, Quality, and Maintenance teams. You will play a key role in maintaining the qualified state of equipment throughout its lifecycle and supporting continuous improvement initiatives.

Key Responsibilities

• Act as a C&Q subject matter expert for equipment qualification activities
• Develop, execute, and maintain commissioning and qualification strategies
• Ensure equipment remains in a validated and compliant state throughout its lifecycle
• Collaborate with Engineering, Operations, Quality, and Maintenance departments
• Represent C&Q during regulatory and client quality audits
• Communicate qualification strategies, progress, and status to stakeholders
• Drive improvements in QMS, C&Q processes, methodologies, and tools
• Provide guidance and mentorship to external C&Q engineers

Required Experience & Skills

• Extensive experience in Commissioning & Qualification (C&Q) within a GMP environment
• Strong knowledge of GMP regulations, including Annex 1 and 21 CFR Part 11
• Proven experience with qualification of:
• Equipment
• Production systems
• Utilities
• Facilities
• Ability to work both strategically and hands-on in a complex pharmaceutical environment
• Strong understanding of compliance, quality systems, and risk-based qualification approaches
• Excellent communication skills with the ability to engage stakeholders at different organizational levels

Ideal Candidate Profile

• Strong hands-on mentality with a passion for C&Q engineering and compliance
• Team player who enjoys collaboration and sharing expertise
• Quality and safety-focused mindset
• Strong interpersonal and communication skills
• Master’s degree in Engineering, Science, or equivalent experience
• Professional English language skills required
• Dutch language skills are highly preferred

Project Context

The site is currently undergoing a major equipment revamp and requalification program, with significant investment planned to support future manufacturing capabilities.

This is an excellent opportunity for an experienced C&Q Engineer to contribute to a high-impact pharmaceutical project within an international environment.