CQV Lead — Biotech Equipment Validation (GMP)

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

Descripción de la vacante

PQE Group in Barcelona seeks an experienced CQV Lead to drive commissioning, qualification, and validation activities in biotechnological production facilities. You will lead C&Q efforts, prepare essential documentation, and ensure adherence to GMP and regulatory standards.

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.

Formación

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• At least 5 years of IQ/OQ/PQ protocol development and C&Q in pharma/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).
• Salary starting at 40,000€ gross per year.

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 GMP compliance and project timelines.
• Review technical documentation, P&IDs, FAT/SAT protocols, and vendor manuals.
• Identify, troubleshoot, and document deviations with 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/EU regulations

Analytical skills

Problem solving

Communication skills

Independent and collaborative work

Spanish native

English fluent

Educación

Bachelor’s degree in Engineering/Life Sciences

Descripción del empleo

PQE Group in Barcelona seeks an experienced CQV Lead to drive commissioning, qualification, and validation activities in biotechnological production facilities. You will lead C&Q efforts, prepare essential documentation, and ensure adherence to GMP and regulatory standards.

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.