CQV Consultant

PQE Group; Barcelona; On-site; EUR 27,000 - 33,000; Full time

Job summary

PQE Group seeks an experienced CQV Consultant in Barcelona to lead commissioning, qualification and validation activities for pharmaceutical/biotech facilities. The role involves drafting and executing URS, DQ, IQ, OQ, and PQ protocols with cross-functional teams to ensure GMP compliance and project timelines.

Requires a Bachelor's degree in Engineering or Life Sciences, 2+ years in IQ/OQ/PQ and C&Q, and fluency in Spanish with English at least B2. Salary starts from 30,000€ gross per year.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences or related field.
• 2+ years in IQ/OQ/PQ and C&Q for pharma/biotech facilities.
• Strong GMP, FDA and EU regulation knowledge.
• Excellent analytical and communication skills.
• Spanish native; English fluent (B2+).

Responsibilities

• 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, 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 to stakeholders.

Skills

IQ/OQ/PQ protocol

C&Q for pharma/biotech facilities

GMP knowledge

Regulatory knowledge

Analytical skills

Education

Bachelors in Engineering/Life Sciences

Job description

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. take the first step towards an amazing future with us.