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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. Job Overview We are looking for a Engineering Project Manager in San Sebastián de los Reyes (Madrid) to lead engineering projects across our manufacturing sites. The role focuses on executing plant modifications, improvements, and new equipment installations, ensuring delivery within scope, budget, and timelines. The ideal candidate has experience in industrial projects within regulated environments, strong leadership and coordination skills, and solid knowledge of GMP and safety standards. Responsibilities: • Lead and coordinate engineering projects related to plant modifications, improvements, and new equipment or facility installations., • Manage cross-functional project teams, including internal personnel and external contractors., • Ensure projects are completed on time, within budget, and in compliance with engineering best practices, safety rules, environmental standards, and GMP regulations., • Oversee the full project life cycle, from URS and design phases through commissioning and start-up (including IQ activities)., • Support OQ, PQ, and production ramp-up., • Prepare and maintain GMP project documentation: change controls, reports, deviations, and CAPAs., • Manage contractors and engineering firms, including issuing and closing work permits., • Control project budgets and ensure proper cost tracking., • Prepare procurement specifications and supervise installation and qualification of equipment and systems., • Provide support to general engineering activities as needed., • Ensure compliance with internal occupational health & safety and environmental policies. Qualifications: • Engineering degree (Technical Engineering or equivalent)., • +5 years of experience in industrial project development and management, production and/or maintenance within the pharmaceutical or cosmetics industry., • English fluent and Spanish native, • Solid understanding of GMP, safety, industrial hygiene, and environmental regulations., • Experience managing suppliers and contractors., • Strong budgeting and cost-control, leadership and team management skills., • User-level proficiency with Microsoft Office, MS Project, AutoCAD, and SAP and knowledge of occupational risk prevention. 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 feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.

Clinical Development Manager Role Overview This role provides operational and scientific support to the Clinical Development team in the planning, execution, analysis, and oversight of preclinical and clinical studies. The position focuses on studies involving pharmacokinetics, toxicology (including toxicokinetics), and analytical validation, ensuring compliance with regulatory requirements, GLP/GCP principles, and internal quality standards. Key Responsibilities Study Planning & Design • Lead the design of preclinical studies and contribute to clinical study design in line with current regulatory requirements for pharmaceuticals and biologics, • Identify, evaluate, and manage external Contract Research Organizations (CROs), ensuring scientific quality, regulatory compliance, adherence to timelines, and budget control, • Oversee study execution at CROs, ensuring protocol compliance and adherence to GLP/GCP standards, • Manage deviations, amendments, and study-related issues, • Review and assess analytical methods and bioanalytical data supporting pharmacokinetic, toxicokinetic, and pharmacology studies, • Calculate and interpret pharmacokinetic parameters, • Contribute to the scientific evaluation of study outcomes, • Maintain accurate, complete, and well-organized study documentation (protocols, contracts, reports, raw data, and correspondence) in line with internal procedures, • Support regulatory activities by preparing or reviewing technical sections of dossiers (e.g., safety, efficacy, pharmacokinetics), • Contribute to expert reports and regulatory submissions, • Stay up to date with relevant regulations, guidelines, and scientific developments, • Contribute to process improvements and provide scientific input to cross-functional teams, • Remote within Europe, the UK, or the US, • Primarily hybrid (home/office-based), with occasional travel for CRO visits, audits, and study-related activities Candidate Profile Education • Degree in Veterinary Medicine, Pharmacy, or a related life science discipline, • Postgraduate training in pharmacology, toxicology, or a related field is highly desirable, • Strong understanding of bioanalysis and pharmacokinetics Experience • Experience within research institutions, universities, CROs, or preferably the pharmaceutical/animal health industry, • Prior involvement in preclinical studies, GLP environments, or pharmacokinetic/toxicology projects is preferred Skills & Competencies • Strong analytical and scientific reasoning skills, • Familiarity with statistical principles, data processing workflows, Excel, and pharmacokinetic modelling tools, • Excellent communication and interpersonal skills with a collaborative, proactive approach, • Ability to manage multiple projects simultaneously while maintaining high-quality documentation, • Strong organizational skills and attention to detail Languages • Fluency in English (spoken and written) is essential, • Additional European languages are considered an advantage