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Analytical Validation Expert

il y a 1 heure


Luik, Belgique Panda International Temps plein

Senior Analytical Validation & Q&V SME (MSAT / PAD / QC) Liège, Belgium – 3-month contract (Hybrid, extension highly likely) Job Description You will join a GMP analytical and MSAT environment supporting biopharmaceutical and ATMP programs , acting as the senior Subject Matter Expert for analytical validation and qualification activities across MSAT, PAD, and QC laboratories . The role focuses on defining and governing analytical validation strategy , ensuring analytical methods are fit for purpose, GMP-compliant, and successfully transferred, while coaching teams and interfacing directly with clients and auditors. Essential Requirements MSc or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related life sciences 5+ years of senior experience in Analytical Validation / Qualification & Validation Proven expertise in: Analytical method validation (ICH Q2 / lifecycle validation) Qualification & Validation strategy definition GMP documentation (protocols and reports) Strong hands-on experience in: Method transfers (client → QC / PAD and internal transfers) Managing deviations, OOS, and invalid results Deep knowledge of: EU GMP and FDA guidelines cGMP analytical requirements in biopharma and/or ATMP environments Ability to work independently at advisory / SME level Excellent scientific writing, data review, and technical decision-making skills Fluent English (written and spoken) Preferred Requirements Experience in ATMP, cell therapy, or gene therapy Strong background in: Total Error approach Bridging strategies for reagents and reference standards Statistical assessment of validation data Experience applying Analytical Quality by Design (aQbD) Client-facing experience, including: IPC and release testing strategy definition Participation in regulatory and client audits French language skills (professional working proficiency) Prior experience coaching or mentoring analytical / MSAT teams Practicalities Start Date: ASAP (immediate availability preferred) Contract Duration: 3 months, extension highly likely Location: Liège, Belgium (hybrid – approx. 3 days/week on-site) Interested? Interviews and offers can move quickly. Send your CV to k.vongeusau@panda-int.com or call +31202044502 today to secure your spot in the process.