Descripción de la oferta
Job Title: Senior CQV EngineerLocation: Salamanca, SpainDuration: 1 Year (Starting May/June 2026) with potential extensionLanguage Requirements: Spanish (essential)Company Overview:Adryan is an internationally operating services group. From our offices in The Netherlands and Switzerland, we offer a full range of services for the (bio)pharmaceutical and high-end food industry. We are specialised in the areas of project management, engineering, CQV and compliance.Position Overview:The Senior CQV Engineer is responsible for executing and supporting Commissioning, Qualification & Validation (CQV) activities for equipment, systems, and facilities, ensuring compliance with Good Manufacturing Practices (GMP), regulatory requirements, and applicable quality standards, while meeting project timelines and objectives.Key Responsibilities:Commissioning¿Es este el siguiente paso en su carrera? Descubra si es el candidato adecuado leyendo la descripción completa a continuación.Participate in commissioning activities for equipment and systems (FAT, SAT, functional testing).Participate actively in construction and/or equipment walkdowns and follow up on open action items.Verify that systems are installed and operate in accordance with design requirements.Collaborate with Engineering, Automation, and vendors during start-up activities. Qualification & ValidationPrepare, review, and execute CQV documentation (URS, DQ, IOQ, PQ).Develop and execute qualification and/or validation protocols and reports.Ensure appropriate requirements traceability.Identify, document, and follow up on deviations and issues.Support requalification activities and change management processes. Regulatory Compliance & QualityEnsure compliance with GMP, FDA, EMA, GAMP 5, ICH, and internal policies and procedures.Participate in internal and external audits (regulatory and/or client audits).Support change impact assessments and Change Control activities. Project Management & CollaborationCoordinate CQV activities with multidisciplinary teams (QA, Engineering, Production, Automation).Report progress, risks, and issues to the CQV Lead and/or Project Manager.Ensure compliance with project schedules and agreed deliverables.Prepare and review system lists, impact assessments, quality tracking tools, and overall project plans developed throughout the project lifecycle. Qualifications & Experience:Bachelor's degree in Engineering (Industrial, Chemical, Mechanical, Electrical, Biomedical, or similar).A Master's degree or specific training in Validation and/or Quality is considered an asset.Proven experience in CQV activities within sterile pharmaceutical manufacturing facilities.Experience with systems and equipment such as HVAC, Utilities (PW, WFI, gases), process equipment, and automated systems is desirable.Experience in reviewing technical and validation documentation, especially in Spanish.Knowledge of GMP regulations and applicable regulatory guidelines.Experience with risk-based validation methodologies.Ability to generate and manage technical documentation and CQV protocols.Knowledge of automation systems and CSV is considered a plus.Excellent organizational and coordination skills to keep tasks on track.Fluency in Spanish; proficiency in English is a plus.Ability to work independently and as part of a multidisciplinary team. Start Date: May/June 2026Duration: 1 year with potential for extensionIf you meet these qualifications and are interested in contributing to a cutting-edge sterile manufacturing environment, please apply with your updated CV.Note: On-site presence will be discussed; partly remote working arrangements are possible. xcskxlj Documentation and systems are accessible online for your convenience.
