Validation Specialist - Manufacturing and Cleaning processes

Michael Page; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A pharmaceutical company in Barcelona seeks a Validation & Qualification Specialist to oversee manufacturing process validation. You will collaborate with teams, ensure compliance with GMP standards, and help launch a new facility. The role offers competitive salary and career growth opportunities in a dynamic environment.

Servicios

Competitive salary

Personalized career development plan

Opportunity to collaborate with experienced professionals

Formación

• Experience in validation of manufacturing and cleaning processes in pharmaceuticals.
• Knowledge of GMP Annex 15.
• Strong analytical skills for root cause analysis.

Responsabilidades

• Lead and execute manufacturing process validation studies.
• Write protocols and reports for validation.
• Design cleaning validation programs.
• Collaborate with teams for process transfer.

Conocimientos

Manufacturing process validation

GMP guidelines

Collaboration with Production teams

Root cause analysis

Educación

Degree in Life Sciences or Engineering

Descripción del empleo

• Pharmaceutical Industry with production plant in the area of Barcelona.
• Qualificaction of manufacturing and cleaning 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 Specialist of manufacturing and cleaning processes 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

• Lead and execute manufacturing process validation studies (new products, revalidations, scale-up changes).
• Write validation protocols and reports following the guidelines of GMP Annex 15 and internal GVMP.
• Collaborate with the Technology Transfer and Production teams to define key process parameters. Provide support during the transfer of new products from the laboratory to the plant, ensuring robust and reproducible production.
• Design and maintain equipment and cleanrooms cleaning validation and revalidation programs, ensuring there is no cross-contamination between products.
• Establish and calculate acceptance criteria and sampling points, and collaborate with the quality control laboratory for residue analysis.
• Evaluate the impact on the validation status, both in cleaning and in validated process when new products intend to be introduced in the facilities.
• Collaborate in root cause analysis and implementation of corrective and preventive actions (CAPAs) related to technical incidents, out-of-specification (OOS) or trending (OOT) results, customer complaints, and deviations during qualified processes.
• Ensure that validation findings are integrated into the quality system and contribute to improving process robustness.
• Active participation in internal audits and regulatory inspections and in the preparation of supporting technical documentation.

?? 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.