CSV Engineer

FAMAR is a European Contract Manufacturing and Development partner, for the Pharmaceutical and Healthcare industry. Building on our 75 years’ expertise, we are your reliable partner to deliver flexible solutions, from development to production and distribution. Driven by our customer-care mindset, we offer services covering the majority of pharmaceutical forms, while providing a particularly strong expertise in Liquids, Ointments and Creams. Through the outstanding knowledge and commitment of our 1.850 employees and with a network of 6 production sites and 2 R&D units, we supply a wide range of 1.800 products for more than 80 international markets.We are currently looking to recruit a professional to fill the position of CSV Engineers, to be based in Greece, Spain and Germany.Job Scope: The CSV Engineer is responsible for the validation and compliance of all computerized systems within the organization. Act as a key point of contact for engineering and project teams, providing expertise and guidance on CSV activities. The role requires a proactive mindset, strong collaboration skills, and a commitment to maintaining the highest standards of quality, data integrity, and regulatory compliance.Main responsibilities: Act as the primary point of contact within Group Engineering for all Computerized System Validation (CSV) activities across projects and departments.Plan, execute, and oversee validation activities for computerized systems — including manufacturing and laboratory equipment, data management systems, and related applications.Develop, analyze, maintain, and ensure completeness and compliance of validation documentation (e.g., validation plans, user and functional requirements, specifications, test protocols, and reports).Ensure all systems comply with GMP, 21 CFR Part 11, Annex 11, internal policies, and best engineering practices.Conduct and document risk assessments, validation tests (IQ/OQ/PQ/UAT), and manage deviations or anomalies through to resolution.Manage change control processes and maintain up-to-date validation files, traceability matrices, and contributions to the Validation Master Plan (VMP) and Periodic Reviews.Provide training to relevant personnel on computerized system validation processes, procedures, and best practices.Participate in audits and inspections as the engineering representative for CSV topics.Manage validation service vendors to ensure that the services provided meet regulatory expectations.Drive best practices and continuous improvement in qualification, validation, lifecycle management, and data integrity across computerized systems.Collaborate with cross-functional and site engineering teams on supplier validation package reviews and system updates.Stay current with evolving regulations, guidelines, and industry trends in computerized system validation.Undertake any other project or responsibility that is assigned by the company, within the broader scope of the position’s responsibilities.Position requirements: Bachelor’s degree in Engineering, Chemistry, Computer Science, or a related technical discipline.At least 5 years of experience in qualification and validation of computerized systems (e.g., PLC/HMI automation systems, laboratory instruments, or data management platforms), preferably within a pharmaceutical or other regulated manufacturing environment.Strong knowledge of GxP regulations and guidelines (EudraLex Volume 4, 21 CFR Part 11, Annex 11) and solid understanding of validation lifecycle processes (IQ/OQ/PQ), risk-based validation, and GAMP5 best practices.Hands-on experience with risk assessment and quality risk management methodologies (e.g., FMEA, PHA).Excellent documentation, troubleshooting, and testing skills.Strong project management, planning, and analytical capabilities, with proven ability to manage multiple priorities.High attention to detail and commitment to quality and data integrity.Excellent command of English, both written and spoken; knowledge of Spanish, Italian, German, or Greek is an advantage.