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) Lead in Barcelona. This role will focus on the qualification and validation of equipment and systems in biotechnological production facilities.

Responsibilities include, but are not limited to:

Execute commissioning, qualification, and validation activities for pharmaceutical/biotech equipment and systems
Prepare, review, and execute C&Q; and validation documentation (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, P&IDs;, 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 stakeholder

Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field
At least 5 years of experience in IQ/OQ/PQ protocol development and execution and C&Q; for pharmaceutical/biotech facilities, including construction of production plants
Strong knowledge of GMP, FDA, and EU regulations
Excellent analytical, problem-solving, and communication skills
Ability to work independently and collaboratively in a project environment.
Spanish native, English fluent (at least B2)
Salary starts from 35.000€ gross per year

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 ar

📌 CQV Lead (España)
🏢 Pqe Group
📍 España