Senior C&Q Consultant

PQE Group; Madrid, Barcelona; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical firm is seeking a Commissioning & Qualification Engineer to support qualification activities in Madrid. Candidates must hold a Bachelor's degree, have around 3 years of related experience, and be fluent in English and Spanish. Responsibilities include preparing C&Q documentation, collaborating with teams, and ensuring compliance with GMP and regulatory standards. Join our multinational team for an exciting career.

Formación

• Approximately 3 years of experience in Commissioning & Qualification within the pharmaceutical/biotech industry.
• Knowledge of GMP, FDA, and EU regulations.
• Experience with IQ/OQ/PQ protocol development and execution.

Responsabilidades

• Support commissioning and qualification activities for pharmaceutical facilities.
• Prepare and execute C&Q documentation.
• Collaborate with cross-functional teams to ensure regulatory compliance.
• Identify, troubleshoot, and document deviations.

Conocimientos

Analytical skills

Problem-solving skills

Communication skills

Teamwork

Independence

Fluency in English

Fluency in Spanish

Educación

Bachelor’s degree in Engineering, Life Sciences, or related field

Descripción del empleo

Overview

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

We are currently seeking a dedicated and motivated Commissioning & Qualification (C&Q) Engineer to support facility, utility, equipment, and system qualification activities in Barcelona and Madrid. The role involves ensuring compliance with GMP requirements, company standards, and regulatory guidelines while contributing to the successful delivery of pharmaceutical projects.

❗ Please note: although the position is listed as Barcelona, we are also considering candidates based in Madrid.

Responsibilities

• Support commissioning and qualification activities for pharmaceutical facilities, utilities, and process equipment.
• Prepare and execute C&Q 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 project timelines and regulatory requirements.
• Review and interpret technical documentation, P&IDs, FAT/SAT protocols, and vendor manuals.
• Identify, troubleshoot, and document deviations, ensuring timely resolution.
• Ensure all C&Q activities are performed in line with GMP, FDA, EMA, and ICH guidelines.
• Participate in project meetings and provide updates on progress, risks, and mitigations.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• ~3 years of experience in Commissioning & Qualification within the pharmaceutical/biotech industry
• Knowledge of GMP, FDA, and EU regulations
• Experience with IQ/OQ/PQ protocol development and execution
• Strong analytical, problem-solving, and communication skills
• Ability to work independently and in teams
• Fluent in English and Spanish (written and spoken)
• Willingness to travel as required

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there\'s a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.