Senior Commissioning & Qualification Engineer - Filling Equipment

Nalys; Wallonië; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Nalys is seeking a Senior Commissioning & Qualification Engineer to join a pharmaceutical site in Belgium and drive the commissioning and qualification of complete filling lines. You will manage FAT/SAT activities and liaise with international suppliers to ensure GMP-compliant documentation and traceability.

The role requires hands-on field expertise, collaboration with Engineering, Production and Quality, and the ability to work across FAT, IQ, OQ and SAT stages on site and abroad.

Qualifications

• Engineering degree or equivalent technical background.
• Hands-on C&Q experience in pharma/GMP environments.
• Experience with filling machines or complete filling lines.
• Strong FAT/SAT background and equipment qualification.
• Able to assess suppliers from technical and GMP/C&Q perspectives.
• Pragmatic, field-oriented profile.
• Fluency in English and French.

Responsabilités

• Prepare, coordinate and execute Commissioning & Qualification activities for filling equipment and associated systems.
• Review equipment design and supplier documentation from a technical, C&Q and GMP perspective.
• Prepare and/or review qualification protocols and documentation.
• Participate in and challenge FAT execution at the equipment manufacturers' facilities abroad.
• Manage FAT observations, punch lists, deviations and corrective actions.
• Support installation, commissioning and start-up of the equipment on site.
• Execute and/or coordinate SAT, IQ and OQ activities.
• Ensure traceability between requirements, testing and qualification documentation.
• Collaborate closely with Engineering, Production, Quality and equipment suppliers.
• Troubleshoot technical and qualification issues and drive them to resolution.

Connaissances

C&Q Engineer

Pharma GMP

Filling lines

FAT/SAT

Qualification docs

Supplier engagement

GMP/C&Q standards

Field-oriented

English & French

Formation

Engineering degree

Description du poste

C&Q Engineer Senior – Filling Equipment

Brabant Wallon, Belgium

About Nalys

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.

At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.

Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description

As a Senior Commissioning & Qualification Engineer, you will join the engineering team of a pharmaceutical manufacturing site in Belgium to support the commissioning and qualification of complete filling lines.

You will be involved across the full equipment lifecycle — from supplier testing and Factory Acceptance Tests through installation, commissioning and qualification on site.

The equipment is supplied by international manufacturers, which means you will interact directly with suppliers and take part in extended FAT campaigns abroad.

This is a hands‑on, field‑oriented role for someone who enjoys following equipment from the factory floor all the way to final qualification.

The Role & Responsibilities

• Prepare, coordinate and execute Commissioning & Qualification activities for filling equipment and associated systems
• Review equipment design and supplier documentation from a technical, C&Q and GMP perspective
• Prepare and/or review qualification protocols and documentation
• Participate in and challenge FAT execution at the equipment manufacturers' facilities abroad
• Manage FAT observations, punch lists, deviations and corrective actions
• Support installation, commissioning and start-up of the equipment on site
• Execute and/or coordinate SAT, IQ and OQ activities
• Ensure traceability between requirements, testing and qualification documentation
• Collaborate closely with Engineering, Production, Quality and equipment suppliers
• Troubleshoot technical and qualification issues and drive them to resolution.

Skills & Qualifications

• You hold an Engineering degree or equivalent technical background
• You have experience as a C&Q Engineer, able to work autonomously
• And solid hands‑on C&Q experience within pharmaceutical / GMP environments
• An experience with filling machines or complete filling lines strongly preferred
• You have a strong background in FAT/SAT and equipment qualification
• You are able to understand and challenge equipment suppliers from both a technical and GMP/C&Q standpoint
• You are pragmatic, field-oriented profile — not purely documentation-focused
• You are fluent in both English and French.

Mandatory Availability

This role requires two extended assignments abroad for FAT activities, each approximately three weeks long, planned for January and February 2027. Availability for both periods is essential and will be confirmed early in the process.

What We Offer

• A human‑scaled consulting company focused on expertise, partnership, and career development
• Long‑term assignments with leading pharmaceutical players
• Continuous learning through technical coaching, training, and knowledge sharing
• A supportive culture that values autonomy, trust, and impact
• An attractive salary package with additional benefits.

Our Recruitment Process

• Talent Acquisition Call

A first discussion with our Talent Acquisition Specialist, Olivia Braszko, to understand your background, motivations, and career goals

• Technical Interview

A meeting with one of our Technical Referent to evaluate your expertise and fit for the mission

• Business Interview
• A conversation with the Business Unit Director, Alexandre Ivankovich, to discuss the project context and your future within Nalys.