Job Title: Senior CQV Engineer
Location: Salamanca, Spain
Duration: 1 Year (Starting May/June 2026) with potential extension
Language Requirements: Spanish (essential)
Por favor, verifique que tiene el nivel de experiencia y las cualificaciones adecuadas leyendo la descripción completa de esta oportunidad a continuación.
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.
* Collaborate with Engineering, Automation, and vendors during start-up activities.
Qualification & Validation
* 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.
* Support requalification activities and change management processes.
Regulatory Compliance & Quality
* 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).
* Support change impact assessments and Change Control activities.
Project Management & Collaboration
* 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. xpzdshu Documentation and systems are accessible online for your convenience.