Laboratory Maintenance Specialist and Qualification

hace 2 días

Barcelona, Barcelona, España Michael Page A tiempo completo

We are seeking a
Laboratory Qualification & Maintenance Specialist
to join a pharmaceutical manufacturing facility located in Vallès Occidental. The role involves managing the qualifications, requalifications and maintenance of laboratort equipment.

Detalles del cliente

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
Laboratory Qualification & Maintenance Specialist
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.

Descripción de la oferta

  • Manage initial qualification and requalification activities for laboratory equipment.
  • Update and maintain the Validation Master Plan for Laboratory Equipment in accordance with EU-GMP Annex 15, USP, 21 CFR, and other applicable standards.
  • Lead the execution of DQ/IQ/OQ/PQ activities for laboratory equipment installations, either directly or by supervising external suppliers.
  • Manage laboratory equipment maintenance in close collaboration with equipment suppliers, including defining service agreements.
  • Review SOPs and Working Instructions related to laboratory equipment to ensure alignment with applicable EU and US GMP regulations, especially regarding equipment use and maintenance.
  • Lead root cause analyses for deviations and manage CAPA execution related to OOS/OOT results, non-conformities, incidents, and complaints within R&D and/or Quality Control.
  • Participate as the subject-matter expert for laboratory equipment during internal and external audits and during regulatory authority inspections.
  • Conduct training for new staff in the R&D/QC departments under Quality Assurance scope, mainly regarding the use of laboratory equipment.
  • Manage the Calibration Plan for Analytical Instruments and support implementation of the Calibration Plan for assigned metrological equipment.

Perfil del candidato

  • Master's degree in Pharmacy, Engineering, Biochemistry, Biotechnology, or Chemistry.
  • Minimum of 3 years of experience in a environment within EU-GMP certified pharmaceutical facilities, preferably in aseptic production of vials and pre-filled syringes.
  • Strong understanding of USP/EP methodologies and ICH guidelines.
  • Demonstrated ability to plan resources and manage priorities to deliver consistently under tight project deadlines.
  • Ability to work independently and solve complex problems.
  • Fluent written and verbal communication skills in both English and Spanish.
  • Strong computer literacy (MS Office, PDF editing tools); SAP knowledge is a plus.
  • Flexible mindset suited for a multinational, multitasking, and multiteam environment.

Oferta de empleo

  • The opportunity to gain deep and hands-on experience in launching a new pharmaceutical manufacturing facility in Spain.
  • Permanent employment contract.
  • Competitive remuneration aligned with proven experience.
  • A collaborative and supportive work environment.

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