CQV Lead

PQE Group; Barcelona; Presencial; EUR 36.000 - 44.000; Jornada completa

Descripción de la vacante

PQE Group in Barcelona is seeking an experienced Commissioning, Qualification & Validation (CQV) Lead to drive equipment and system qualification in biotechnological production facilities. You will execute CQV activities, prepare and review URS, DQ, IQ, OQ, PQ protocols, and collaborate with Engineering, QA, Validation and Manufacturing to meet GMP, FDA, EMA, and ICH requirements.

Fluency in Spanish and English is required, with a strong track record in regulated environments.

Formación

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years' experience in IQ/OQ/PQ protocol development and C&Q for pharma/biotech facilities.
• Strong knowledge of GMP, FDA, and EU regulations.
• Spanish native; English at least B2.
• Ability to work independently and in cross-functional teams.

Responsabilidades

• Execute commissioning, qualification, and validation activities for pharma/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 Engineering, QA, Validation, Manufacturing to ensure GMP/regulatory compliance and 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 stakeholders.

Conocimientos

IQ/OQ/PQ protocol development

GMP/FDA knowledge

Analytical/problem-solving

Communication skills

Independent & collaborative work

Educación

Bachelor’s degree in Engineering or Life Sciences

Descripción del empleo

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.