CQV Project Manager

PQE Group; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in León, Spain, seeks an experienced CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical and biotech systems. The ideal candidate will possess a relevant Bachelor's degree and proven experience in CQV. Strong knowledge of GMP and FDA regulations is essential, as is fluency in English and Spanish. Join to work on international projects and develop your skills in a rewarding environment.

Servicios

International project opportunities

Skill development

Formación

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Proven experience in CQV for pharmaceutical / biotech facilities.
• Strong knowledge of GMP, FDA, and EU regulations.

Responsabilidades

• Lead commissioning and validation activities for pharmaceutical equipment.
• Prepare and review C&Q documentation like URS, DQ, IQ, OQ, PQ.
• Collaborate with teams to ensure compliance with regulatory guidelines.

Conocimientos

Fluent in English and Spanish

Analytical skills

Problem-solving

Communication skills

Educación

Bachelor’s degree in Engineering or Life Sciences

Descripción del empleo

Overview

Are you ready to join a world leader in the exciting and dynamic fields of the pharmaceutical and medical device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

We are currently seeking an experienced Commissioning, Qualification & Validation (CQV) Project Manager in León, Spain.

Responsibilities

• Lead and execute commissioning, qualification, and validation activities for pharmaceutical / biotech equipment and systems.
• Prepare, review, and execute C&Q and validation documentation including URS, DQ, IQ, OQ, PQ protocols, test scripts, and summary reports.
• Collaborate with cross‑functional teams (Engineering, QA, Validation, Manufacturing) to ensure compliance with GMP regulatory guidelines and project timelines.
• Review technical documentation such as P&ID, FAT/SAT protocols, and vendor manuals.
• Identify, troubleshoot, and document deviations, ensuring timely resolution.
• Ensure all activities meet GMP, FDA, EMA, and ICH requirements.
• Provide project updates and progress reports to stakeholders.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Proven experience in CQV for pharmaceutical / biotech facilities, including construction of production plants.
• Strong knowledge of GMP, FDA, and EU regulations.
• Experience in IQ / OQ / PQ protocol development and execution.
• Excellent analytical, problem‑solving, and communication skills.
• Ability to work independently and collaboratively in a project environment.
• Fluent in English and Spanish, written and spoken.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there’s a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome from the Hiring Manager interview, the recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

• PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
• If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.