Process Engineer – Equipment

hace 3 días


Madrid, España Adryan A tiempo completo

Job TitlePresente su candidatura después de leer los siguientes requisitos de habilidades y cualificaciones para este puesto.Process Engineer – Equipment & CQV Support (mAb Manufacturing)LocationBarcelona, Spain (on-site / hybrid)Engagement TypeContractDuration10 months with possibility of extensionRole OverviewAdryan is seeking aProcess Engineerto support a monoclonal antibody (mAb) program through the specification, procurement, installation, and qualification of manufacturing and quality control equipment. The role will work closely with manufacturing, QC, quality, engineering, and external vendors to ensure equipment is fit for purpose, compliant with GMP requirements, and ready for operational use.Key ResponsibilitiesSupport the definition of User Requirement Specifications (URS) for manufacturing and QC equipment used in mAb production.Provide technical input into vendor selection, evaluations, and purchase decisions; review vendor documentation, FAT / SAT protocols, and technical design packages.Act as on-site engineering support during equipment delivery, installation, and commissioning; coordinate with vendors, facilities, automation, and validation teams, and resolve technical issues arising during installation or start‑up.Support or lead IQ/OQ (and PQ where applicable) for manufacturing and QC equipment; ensure qualification activities align with GMP, internal standards, and regulatory expectations; review and approve CQV documentation, protocols, and final reports.Interface with process development, manufacturing, QC, QA, and external suppliers; support knowledge transfer to operations and quality teams for long‑term equipment use.Required Qualifications & ExperienceEducationDegree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related technical discipline.ExperienceSupporting mAb or biologics manufacturing environments; hands‑on experience with equipment specification, installation, and CQV in a GMP‑regulated setting; familiarity with manufacturing and/or QC equipment typically used in biologics facilities (bioreactors, chromatography systems, filtration, analytical / QC instruments); experience working with vendors and managing on‑site activities during installation and qualification phases.Skills & CompetenciesStrong understanding of GMP and GxP requirements.Practical, solution‑oriented engineering mindset.Ability to work independently while coordinating with cross‑functional teams.Clear and effective communication skills.Comfortable operating in a project‑based, fast‑paced environment.Language & LocationFluency inEnglish(required) ; Spanish strongly preferred. Ability to work on‑site in Barcelona during key project phases. xsgfvud Why This RoleDirect involvement in a high‑visibility mAb manufacturing project; hands‑on ownership from equipment selection through qualification; opportunity to act as the local technical interface between client teams and vendors.#J-18808-Ljbffr



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