Experienced CQV Lead - Barcelona (Biotech/Pharma)

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

Descripción de la vacante

PQE Group in Barcelona is seeking an experienced Commissioning, Qualification & Validation (CQV) Lead to drive equipment and system qualification in biotechnological production facilities. You will execute CQV activities, prepare and review URS, DQ, IQ, OQ, PQ protocols, and collaborate with Engineering, QA, Validation and Manufacturing to meet GMP, FDA, EMA, and ICH requirements.

Fluency in Spanish and English is required, with a strong track record in regulated environments.

Formación

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years' experience in IQ/OQ/PQ protocol development and C&Q for pharma/biotech facilities.
• Strong knowledge of GMP, FDA, and EU regulations.
• Spanish native; English at least B2.
• Ability to work independently and in cross-functional teams.

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 Engineering, QA, Validation, Manufacturing to ensure GMP/regulatory compliance and 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

IQ/OQ/PQ protocol development

GMP/FDA knowledge

Analytical/problem-solving

Communication skills

Independent & collaborative work

Educación

Bachelor’s degree in Engineering or Life Sciences

Descripción del empleo

PQE Group in Barcelona is seeking an experienced Commissioning, Qualification & Validation (CQV) Lead to drive equipment and system qualification in biotechnological production facilities. You will execute CQV activities, prepare and review URS, DQ, IQ, OQ, PQ protocols, and collaborate with Engineering, QA, Validation and Manufacturing to meet GMP, FDA, EMA, and ICH requirements.

Fluency in Spanish and English is required, with a strong track record in regulated environments.