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 devices, seeks a CQV Consultant in Barcelona to qualify and validate equipment and systems in biotech facilities.

Require a engineering or life sciences degree, 2+ years in IQ/OQ/PQ/C&Q, and strong GMP/FDA/EMA knowledge. Spanish native, English fluent; salary from 30,000€ gross per year.

Formación

• Bachelor's degree in Engineering, Life Sciences, or related field.
• At least 2 years of IQ/OQ/PQ protocol development and execution and C&Q for pharmaceutical/biotech facilities.
• 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).

Responsabilidades

• 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.

Conocimientos

Spanish (native)

English (fluent)

Educación

Bachelor's degree in Engineering or Life Sciences

2+ years IQ/OQ/PQ/C&Q experience

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 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 2 year 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

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.