CQV Consultant (Comunidad de Madrid)

Commissioning, Qualification & Validation Consultant – Madrid

This role focuses on the qualification and validation of equipment and systems in biotechnological production facilities in Madrid.

Responsibilities

• 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 stakeholders.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences or related field.
• At least 2 years 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 speaker, English fluent (at least B2).
• Salary starts from €30,000 gross per year.