Manufacturing Validation Lead

Akkodis; Antwerpen; On-site; EUR 70,000 - 100,000; Full time

Job summary

Akkodis is seeking a Manufacturing Validation Lead in Belgium to oversee validation activities across the product lifecycle, including plans, protocols, risk assessments and reports. The role ensures compliance with GMP, GDP and global standards, collaborating with cross-functional teams and external CMOs.

You will act as a Validation SME for regulatory submissions and inspections, driving quality and continuous improvement within FUE, Process Validation and Comparability initiatives.

Qualifications

• Proven ability to communicate in Dutch and English, both written and verbal.
• Strong cross-functional collaboration across teams and functions.
• Experience in project management within validation projects.
• Sound decision-making, negotiation and problem-solving skills.
• GxP quality systems understanding (GMP, GDP, ISO13485, MDSAP).
• Hands-on expertise in equipment qualification and validation workflows.

Responsibilities

• Create, review, approve, and execute validation plans, protocols, risk assessments and reports for transport and process validation.
• Review CMOs’ qualification/validation data and reports for completeness.
• Assess validation impact from change controls, deviations, audits and CAPAs.
• Support CPV protocols, APQR and Control Process Validation studies.
• Serve as validation SME for regulatory submissions, health authority questions and inspections.
• Ensure validated processes comply with GMP/GDP and CMOs' requirements.
• Contribute to COP activities by sharing best practices and roadmap input.

Skills

Dutch/English comms

Cross-functional collab

Project management

Decision making

GxP knowledge

Equipment qualification

Job description

Akkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and R&D; from consulting and talent solutions to end‑to‑end project delivery. Driven by passion, expertise and impact, we make incredible happen.

In Belgium, we operate through 7 dedicated practices, where our consultants receive the technical guidance, coaching and support they need to grow and fully unlock their potential. We believe in empowering our talent by providing the right expertise, knowledge‑sharing and development opportunities to help them thrive. Our practices: Product & System Development, Validation & Verification, Manufacturing & Operations, Cloud Infrastructures & Security, Data Analytics & Artificial Intelligence, Digital & Software and Wireless & Connectivity.

Akkodis is part of the Adecco Group. You can find more information on our website : www.akkodis.com

As a Manufacturing Validation Lead, you will oversee validation activities across the product lifecycle. This role is responsible for the creation, review, approval, and execution of validation plans, protocols, risk assessments, and reports, with direct involvement in lifecycle management and validation impact assessments tied to change controls, deviations, audit and inspection findings, and CAPAs.

The position serves as a Quality validation SME for regulatory submissions, audits, and inspections, with responsibility for maintaining compliance with GMP, GDP, global standards, and international regulations. It also requires cross‑functional collaboration, participation in product core teams, and active engagement in Communities of Practice focused on Facilities, Utilities and Equipment (FUE), Process Validation, Control Strategy, and Comparability.

Your responsibilities

• Create, review, approve, and execute transport validation plans, protocols, risk assessments, and reports with accuracy.
• Review CMO‑generated qualification and validation protocols, data, and reports to confirm technical completeness.
• Assess validation impact from change controls, deviations, audit and inspection findings, and CAPAs.
• Support process validation, CPV protocols, APQR and Control Process Validation reports, and related studies.
• Act as a transport and process validation Quality SME for submissions, dossier variations, and Health Authority questions.
• Ensure validated transport processes remain compliant with GMP and GDP requirements applied by CMOs or service providers.
• Support CMO audits and inspections as a validation Quality SME when needed.
• Participate in COP activities by sharing best practices, proposing simplification, and contributing to roadmap objectives.

What skills do you bring to the table?

• You have appropriate training and expertise in the COP area you support.
• You have excellent oral and written Dutch & English communication skills with strong attention to detail and accuracy.
• You bring strong interpersonal and negotiation skills in cross‑functional environments.
• You can manage multiple projects with strong organization and consistent follow‑through.
• You demonstrate independent decision‑making, sound judgment, and discretion in your work.
• You have in‑depth experience in equipment qualification, requalification, and shipping validation.
• You are an expert in the Validation Lifecycle Approach and risk‑based validation methods.
• You have experience with cGMP, ISO13485, and MDSAP, along with strong digital skills.

Our recruitment process

Stage 1: Initial telephone interview (15 min) with @Bo, Talent Acquisition Specialist.

Step 2: Interview (60 min) with a Business Manager.

Step 3: Interview (60 min) with the client.