CQV Lead - Biotech Equipment Validation & GMP

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

Descripción de la vacante

PQE Group is seeking an experienced CQV Lead in Barcelona to drive commissioning, qualification and validation activities for pharmaceutical/biotech facilities. You will lead IQ/OQ/PQ protocol development and ensure GMP, FDA and EU regulatory compliance.

The role requires a Bachelor’s degree in Engineering or Life Sciences, 5+ years of IQ/OQ/PQ/C&Q experience, and fluency in Spanish and English. Join a world leader delivering critical projects across global sites.

Formación

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• At least 5 years of IQ/OQ/PQ protocol development and execution and C&Q for pharmaceutical/biotech facilities.
• Strong knowledge of GMP, FDA, and EU regulations.
• Spanish native, English fluent (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 to ensure GMP compliance and timelines.
• Review technical documentation, P&IDs, FAT/SAT protocols, and vendor manuals.
• Identify, troubleshoot, and document deviations; ensure timely resolution.
• Provide project updates to stakeholders.

Conocimientos

Spanish native

English fluent

Analytical skills

Problem-solving

Communication skills

Educación

Bachelor’s degree in Engineering or Life Sciences

Descripción del empleo

PQE Group is seeking an experienced CQV Lead in Barcelona to drive commissioning, qualification and validation activities for pharmaceutical/biotech facilities. You will lead IQ/OQ/PQ protocol development and ensure GMP, FDA and EU regulatory compliance.

The role requires a Bachelor’s degree in Engineering or Life Sciences, 5+ years of IQ/OQ/PQ/C&Q experience, and fluency in Spanish and English. Join a world leader delivering critical projects across global sites.