CQV Consultant: Pharma/Biotech Validation in Barcelona

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

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.