Publiée le 14 juin
Mission du poste
Who we are 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. We believe in empowering our talent by providing the right expertise, knowledge-sharing and development opportunities to help them thrive. Product & System Development, Validation & Verification, Manufacturing & Operations, Cloud Infrastructures & Security, Data Analytics & Artificial Intelligence, Digital & Software and Wireless & Connectivity.
You will cover a broad range of biopharmaceutical processing systems, including bioreactors, centrifuges, buffer/media vessels, chromatography columns, and filtration skids, as well as utilities, HVAC, parts washers, and autoclaves. You will work closely with construction, manufacturing, quality, engineering, and commissioning groups to ensure that systems meet design intent and regulatory expectations.
Take direct responsibility within the Validation team for the successful qualification of defined systems according to the overall CQV schedule and safety requirements.
Execute start-up activities for assigned systems, ensuring they are performed safely, with high quality, and in alignment with project timelines and design intent requirements.
Apply validation methodologies that comply with EU Annex 15 and US 21CFR210/211/600 GMP regulations, as well as specific internal company quality requirements and standards.
Verify technical documentation, including welding and material packages from vendors and passivation, air break, and IO verification sheets from commissioning teams, as part of IQ execution activities.
Perform ‘as built’ field verifications based on P&ID’s to confirm that installations match design and that all components are correctly installed and documented.
Generate IQ/OQ reports that accurately reflect executed qualification tests and clearly document results, deviations, and conclusions for assigned systems.
Engage with technical support functions, including process and automation teams, to resolve issues quickly as they arise during qualification execution phases.
Collaborate with construction, manufacturing, quality, engineering, and commissioning groups to ensure that design intent is met and proven through start-up and qualification activities.
Report regularly on progress to the project Qualification Lead and contribute to status updates, planning discussions, and adjustments required to meet project objectives.
Demonstrated knowledge of pharmaceutical plant qualification, preferably gained in a biotechnology process environment with exposure to bioreactors and related systems.
Knowledge of process and clean utility design, including systems that supply and distribute clean utilities to manufacturing and support areas within regulated facilities.
Proficiency with computer operating systems and applications such as Windows, MS Word, and Excel, enabling efficient preparation and management of validation documentation and reports.
Relevant technology degree or equivalent qualification that supports understanding of biopharmaceutical processes, utilities, and automation systems used in regulated environments.
Knowledge of EU and US Pharmacopoeia and their relevance to pharmaceutical and biotechnology manufacturing operations and quality requirements.
Operating experience in the pharmaceutical industry, ideally within a biotechnology process environment, including exposure to plant operations and regulated GMP practices.
Specific experience in qualification of HVAC, cleanrooms including thermo-mappings, LAF systems, Clean Utilities, Parts Washers, and Autoclaves in accordance with defined protocols.
Good communication skills in both Dutch and English
Stage 1: Initial telephone interview (15 min) with @Bo, Talent Acquisition Specialist.
