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

📌 CQV Lead (Madrid)
🏢 Pqe Group
📍 Madrid