Descripción de la oferta
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 an experienced Commissioning, Qualification & Validation (CQV) Consultant in León, Spain . This role will focus on the qualification and validation of equipment and systems in biotechnological production facilities . Responsibilities include, but are not limited to: 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. + 5 year 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, English fluent (at least B2) 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.
