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CQV Project Manager
hace 3 semanas
Are you ready to join aA continuación se detalla todo lo que necesita saber sobre lo que implica esta oportunidad, así como lo que se espera de los solicitantes.world leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries? PQE Grouphas been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas. We are currently seeking anexperiencedCommissioning, Qualification & Validation (CQV) Project ManagerinLeón, Spain. This role will focus on thequalificationandvalidationofequipmentandsystemsinbiotechnological production facilities.
Responsibilities
include, but are not limited to:Lead andexecute commissioning, qualification, and validation activitiesforpharmaceutical/biotech equipmentandsystems. Prepare, review, andexecute C&Q and validation documentation( URS, DQ, IQ, OQ, PQ protocols,test scripts, andsummary reports). Collaboratewithcross-functional teams( Engineering, QA, Validation, Manufacturing) to ensurecompliancewithGMP,regulatory guidelines, andproject timelines. Reviewtechnical documentation,P&IDs,FAT/SAT protocols, andvendor manuals.
Identify,troubleshoot, anddocument deviations, ensuringtimely resolution. Ensure all activities meetGMP,FDA,EMA, andICH requirements. Provideproject updatesandprogress reportstostakeholders. Required Qualifications:Bachelor’s degreeinEngineering, Life Sciences, or related field.
ProvenexperienceinCQVforpharmaceutical/biotech facilities, includingconstruction of production plants. Strong knowledge ofGMP,FDA, andEU regulations.
Experience
inIQ/OQ/PQ protocol developmentandexecution. Excellentanalytical,problem-solving, andcommunication skills. Ability to workindependentlyandcollaborativelyin aproject environment. Fluent inEnglishandSpanish( written and spoken).
Next StepsUpon 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 GroupAs a member of the PQE team, you will be part of achallenging, multicultural company that values collaboration and innovation. xsgfvud 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.
