🌟 What You'll Be Doing:Develop, review, and execute qualification and validation protocols in line with EU-GMP Annex 15 under the guidance of the V&Q Department Head.Actively participate in SAT, FAT, IOQ/PQ activities for assigned manufacturing utilities and equipment.Supervise external contractors performing validation and qualification tasks.Prepare and review risk assessments to define testing scopes and requalification activities.Support root cause analysis investigations, CAPAs, and quality events (OOS/OOT, deviations, complaints, etc.) related to validation processes.Create and maintain SOPs, Work Instructions, and related documentation to support validation and qualification operations.Provide back-office support during regulatory inspections and internal/external audits.Assist with maintenance and calibration activities for laboratory, warehouse, and production equipment.Pharmaceutical Industry with production plant in the area of Barcelona.Validation & Compliance Specialist for equipment and processes.🎓 What We're Looking For:Degree in Engineering, Pharmacy, Biotechnology, Chemistry, or related scientific field.At least 3 years of experience in a GMP-certified pharmaceutical environment, ideally in aseptic production.Strong knowledge of EU-GMP Annexes 15 and 11 for validation and qualification processes.Ability to manage multiple priorities and meet project deadlines with precision.Independent thinker with solid problem-solving skills.Excellent communication skills in English and Spanish, both written and spoken.Strong computer literacy, including MS Office and PDF tools for document creation and review.Team-oriented mindset with flexibility to thrive in a multicultural, cross-functional, fast-paced environment.Are you ready to take part in building something new from the ground up? A well-established and internationally expanding pharmaceutical company is setting up a state-of-the-art manufacturing and R&D facility in Vallès Occidental (Barcelona) - and we're looking for a Validation & Qualification Technician to play a key role in this journey.The new site will operate as a Contract Manufacturing Organization (CMO), specializing in aseptic filling of generic and biosimilar products. In addition, the company will conduct R&D activities and manage technology transfer and FDF imports into EU markets from third countries.🎁 What We Offer:A unique opportunity to be part of the launch and growth of a brand-new pharmaceutical facility in Spain.Collaboration with experienced professionals and strategic partners across Europe's pharmaceutical industry.Competitive salary, aligned with your skills and experience.A clear and personalized career development plan, with the chance to grow alongside the project.
