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

- 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

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

#J-18808-Ljbffr

📌 CQV Lead (Barcelona)
🏢 Pqe Group
📍 Barcelona