CQV Consultant

PQE Group; Barcelona; Presencial; EUR 27.000 - 33.000; Jornada completa

Descripción de la vacante

PQE Group, a world leader in pharmaceutical and medical device industries, is seeking an experienced CQV Consultant in Barcelona to support commissioning, qualification and validation of biotech facilities.

You will prepare and execute IQ/OQ/PQ protocols, review P&IDs and documentation, and collaborate with Engineering, QA and Manufacturing to ensure GMP, FDA, EMA and ICH compliance.

Formación

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• At least 2 years of IQ/OQ/PQ and C&Q for pharma/biotech facilities.
• Spanish native, English fluent (at least B2) and strong GMP knowledge.

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 cross‑functional teams (Engineering, QA, Validation, Manufacturing) to ensure GMP compliance 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 stakeholders

Conocimientos

CQV

GMP

FDA regulations

EU regulations

QA

Engineering

Validation

Manufacturing

P&IDs

Documentation

Educación

Bachelor’s degree in Engineering, Life Sciences, or related field

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) Consultant 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

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• At least 2 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 30.000€ gross per year