PE Launch Excellence

Akkodis; Antwerpen; On-site; EUR 65,000 - 95,000; Full time

Job summary

Akkodis Belgium is seeking a Quality Validation Specialist to manage all validation aspects for new product launches in a GMP pharmaceutical environment. You will ensure processes meet regulatory requirements and maintain robust documentation.

You will collaborate with QA, production, R&D, and external partners to align validation activities with site objectives, coordinate risk assessments, and drive timely product launch milestones.

Qualifications

• Master's degree in a relevant scientific field.
• Excellent Dutch and good English written and spoken.
• At least 2 years of GMP experience in pharma/biotech.
• Experience with validation projects, protocols, and documentation.
• Strong communication, independent work style and attention to detail.
• Willingness to work early/late/weekends as needed.
• PhD considered an advantage for complex problems.
• Experience with aseptic formulation, filling, and inspection.

Responsibilities

• Validate and document processes for formulation, filling, inspection, shipping, and packaging per GMP.
• Execute and document urgent quality investigations with clear stakeholder communication.
• Draft validation and investigation protocols and coordinate sampling and testing.
• Perform risk analyses for new product introductions and define mitigations.
• Coordinate process and system changes for product introductions across functions.
• Manage project activities: planning, issue resolution, progress reporting, stakeholder updates.
• Collaborate with QA, lab, production, R&D, scheduling, and external partners.

Skills

Dutch language

English language

GMP experience

Validation projects

Project coordination

Strong communication

Technical writing

Education

Master's degree in Bioengineering/Pharmacy/Biochemistry/Biotechnology

PhD degree (advantage)

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

You will support the introduction of new products. In this role, you will be responsible for managing all validation aspects associated with new product launches, ensuring processes meet GMP requirements and applicable regulations throughout the full product lifecycle. You will work closely with cross-functional stakeholders to coordinate process and system changes and to maintain robust documentation. This position requires strong technical expertise, precise project coordination, and the ability to perform risk assessments and quality investigations in a complex pharmaceutical environment.

Your responsibilities

• Validate and document processes for formulation, filling, inspection, shipping, and packaging in accordance with GMP and applicable regulatory requirements.
• Execute and thoroughly document urgent quality investigations, ensuring timely resolution and clear communication to relevant stakeholders.
• Draft detailed validation and investigation protocols, and coordinate sampling activities and required laboratory or in-process testing.
• Perform structured risk analyses for new product introductions and define appropriate mitigation measures to control identified risks.
• Coordinate and implement process and system changes associated with product introduction, ensuring alignment with operational, quality, and regulatory expectations.
• Manage project activities including planning, issue resolution, progress reporting, and stakeholder communication to ensure successful product launch milestones.
• Collaborate closely with Quality Assurance, laboratory, production, scheduling, Research & Development, and external partners to align validation activities with broader site objectives.

What skills do you bring to the table?

• Master’s degree in Bioengineering, Pharmacy, Biochemistry, Biotechnology, or an equivalent scientific or technical discipline relevant to pharmaceutical manufacturing.
• Perfect Dutch language skills and good English language skills, both spoken and written, to manage documentation, communication, and regulatory interactions effectively.
• At least 2 years of experience working in a GMP environment, ideally within pharmaceutical or biotech production and validation activities.
• Demonstrated experience with validation projects and project coordination, including protocol development, execution oversight, and documentation management.
• Strong communication skills and a hands‑on approach, with the ability to work independently while remaining organized, accurate, and quality-focused.
• Willingness and flexibility to work early, late, and weekend shifts during defined limited periods, depending on project and production needs.
• Ph.D. degree is considered an advantage, particularly for complex technical problem‑solving and advanced data analysis tasks.
• Experience with aseptic processes, including formulation, filling, and inspection, and strong technical writing skills for protocols and reports.

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.