• Pharmaceutical Industry with production plant in the area of Barcelona.
• Validation & Compliance Specialist for equipment and processes.

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 You'll Be Doing:

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  Develop, review, and execute qualification and validation protocols in line with EU-GMP Annex 15 under the guidance of the V&Q Department Head.


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  Actively participate in SAT, FAT, IOQ/PQ activities for assigned manufacturing utilities and equipment.


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  Supervise external contractors performing validation and qualification tasks.


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  Prepare and review risk assessments to define testing scopes and requalification activities.


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  Support root cause analysis investigations, CAPAs, and quality events (OOS/OOT, deviations, complaints, etc.) related to validation processes.


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  Create and maintain SOPs, Work Instructions, and related documentation to support validation and qualification operations.


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  Provide back-office support during regulatory inspections and internal/external audits.


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  Assist with maintenance and calibration activities for laboratory, warehouse, and production equipment.

?? What We Offer:

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  A unique opportunity to be part of the launch and growth of a brand-new pharmaceutical facility in Spain.


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  Collaboration with experienced professionals and strategic partners across Europe's pharmaceutical industry.


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  Competitive salary, aligned with your skills and experience.


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  A clear and personalized career development plan, with the chance to grow alongside the project.

?? What We're Looking For:

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  Degree in Engineering, Pharmacy, Biotechnology, Chemistry, or related scientific field.


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  At least 3 years of experience in a GMP-certified pharmaceutical environment, ideally in aseptic production.


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  Strong knowledge of EU-GMP Annexes 15 and 11 for validation and qualification processes.


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  Ability to manage multiple priorities and meet project deadlines with precision.


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  Independent thinker with solid problem-solving skills.


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  Excellent communication skills in English and Spanish, both written and spoken.


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  Strong computer literacy, including MS Office and PDF tools for document creation and review.


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  Team-oriented mindset with flexibility to thrive in a multicultural, cross-functional, fast-paced environment.