Senior CQV Engineer
hace 5 días
Salamanca
Job Title: Senior CQV Engineer Location: Salamanca, Spain Duration: 1 Year (Starting May/June 2026) with potential extension Language 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 • 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., • Prepare, 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., • Ensure compliance with GMP, FDA, EMA, GAMP 5, ICH, and internal policies and procedures., • Participate in internal and external audits (regulatory and/or client audits)., • Coordinate 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 2026 Duration: 1 year with potential for extension If 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. Documentation and systems are accessible online for your convenience.
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