Descripción de la oferta
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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