CSV PM (Computer System Validation) .

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. Position Overview We are looking for a CSV Project Manager to join our team and lead Computer System Validation activities for projects within the pharmaceutical and life sciences industries. This role is responsible for overseeing validation strategies, coordinating project execution, ensuring compliance with regulatory requirements, and serving as the main point of contact between clients and internal teams. Key Responsibilities - Lead and manage Computer System Validation (CSV) projects from planning through execution and closure. - Define validation strategies and ensure alignment with GxP, 21 CFR Part 11, Annex 11, GAMP 5, and internal quality standards. - Coordinate cross-functional teams involved in validation activities, including QA, IT, Engineering, and Operations. - Prepare, review, and approve validation documentation such as: - Validation Plans - Risk Assessments - URS / FS / DS - IQ / OQ / PQ protocols - Traceability Matrices - Final Reports - Monitor project timelines, deliverables, resources, and budgets to ensure successful project completion. - Identify project risks and develop mitigation plans to maintain compliance and project continuity. - Act as the main liaison with clients, providing updates, technical guidance, and project follow-up. - Ensure all validation activities are properly documented and executed in accordance with company procedures and regulatory expectations. - Support audits and inspections related to CSV documentation and processes. - Promote continuous improvement initiatives in validation processes and project execution. Requirements - Bachelor’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Information Systems, or a related field. - Proven experience in Computer System Validation within the pharmaceutical, biotech, or medical device industry. - Previous experience in a Project Management or coordination role. - Strong knowledge of: - GAMP 5 - 21 CFR Part 11 - EU Annex 11 - Data Integrity principles - GxP regulations - Experience validating computerized systems such as ERP, LIMS, MES, SCADA, BMS, SAP, and other GxP systems. - Strong documentation, communication, and stakeholder management skills. - Ability to manage multiple projects and priorities in a fast-paced consulting environment. - Advanced English level is highly preferred. Preferred Qualifications - Experience working in consulting companies or multinational environments. - Knowledge of risk-based validation approaches. - PMP certification or project management training is a plus. - Experience with global clients and cross-regional teams. 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.

Creado: Jue, 01 de Ene de 1970