• 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.

?? What We're Looking For:

• Master's degree in engineering, pharmacy, biochemistry, biotechnology, chemistry or scientific related area.


• Minimum 3 years of work experience in pharmaceutical environment for pharmaceutical premises which are under the EU-GMP certification, preferably in the aseptic production lines for vials and pre-filled syringes.


• Good computer literacy skills in MS Office package as well as statistical software such as Minitab.


• Experience in Validation under the annex 15 of EU-GMP guidelines.


• Proven ability to manage priorities to consistently deliver on time against tight project deadlines.


• Ability to work independently and to solve problems.


• Ability to effectively and clearly communicate into English and Spanish- both written and verbal.


• Flexible mind for work in a multinational, multitask and multiteam environment.