Requirements: English
Company: PQE Group
Region: Gorguja , Catalonia
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 detail-oriented GMP Compliance & Qualification Engineer to support the Engineering and Maintenance department in ensuring strict adherence to GMP regulations. The role involves overseeing qualification activities, managing quality documentation, supporting technical change controls, and ensuring data integrity in line with current regulatory expectations.
Please note: Although the primary location for this role is Barcelona, for approximately the first 6 months the selected candidate will be required to work 100% on-site in Celr (Girona province). Responsibilities include, but are not limited to: * Manage GMP requirements applicable to the Engineering and Maintenance department. * Conduct investigations related to incidents, deviations, OOS, and manage the associated CAPAs. * Prepare, evaluate, implement, and follow up on Quality Risk Assessments (QRA) for both new and existing facilities. * Lead commissioning and qualification processes for new installations. * Liaise with vendors and review documentation to execute qualification tests. * Develop and maintain the annual qualification plan. * Draft and manage User Requirement Specifications (URS) and qualification protocols. * Execute qualification documentation and ensure compliance throughout the lifecycle. * Manage and execute Technical Change Controls. * Ensure proper facility design aligned with all applicable GMP requirements. * Support the Maintenance team in documentation management. * Implement and ensure compliance with data integrity and computerized systems validation (CSV) requirements. * Execute additional tasks as assigned by the Engineering department. Required Qualifications: * Bachelor''s degree in Engineering, Life Sciences, or related field. * Strong knowledge of GMP regulations and pharmaceutical engineering practices. * Experience in equipment qualification, validation, and technical documentation. * Familiarity with data integrity requirements and computerized system validation (CSV). * Analytical mindset and attention to detail. * Ability to work cross-functionally and communicate effectively with vendors and internal stakeholders. * Fluency in English and Spanish is 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.