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 thequalification 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 starting at 40,000€ gross per year

Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. 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.

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📌 CQV Lead (Madrid)
🏢 Pqe Group
📍 Madrid