Computerized System Validation (CSV) Manager
This role manages the validation of computerized systems within the pharmaceutical sector. It offers a flexible schedule, hybrid work, and a flexible benefits plan.
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Nice to have
This job advert was originally written in Spanish.
• 3 - 5 years of experience in validation and qualification activities within regulated environments.
• Knowledge of applicable pharmaceutical regulations and quality standards (GMP/GxP).
• Experience in drafting and executing protocols DQ, FAT, SAT, IQ and OQ.
• Ability to interpret and manage customer requirements related to validations and qualifications.
• Ability to coordinate activities with multidisciplinary teams and clients.
• Strong organizational, documentation and project tracking skills.
• Availability to travel to client facilities as needed.
• B2 - C1 English level
• Previous experience with manufacturers of machinery or equipment for the pharmaceutical industry.
• Knowledge of instrument and measurement system calibration.
• Experience managing external qualification and validation suppliers.
• Knowledge of sterilization, aseptic filling processes or pharmaceutical equipment.
• Familiarity with audits, inspections and highly regulated GMP environments.
Permanent contract.
Flexible compensation program (medical insurance, public transport ticket and childcare voucher)
Discounts at gym networks (Urban Sports Club)
Training and development.
Employee referral program.
Our goal is your well-being in every sense!
We are looking for a Validation Technician to join a leading company in the pharmaceutical and equipment manufacturing sector, participating in equipment and facility qualification and validation projects under GMP regulations.
The selected person will be responsible for ensuring compliance with pharmaceutical quality standards and customer requirements, participating in all phases of project validation and qualification.
• Ensure project quality through the proper execution of validation and qualification activities.
• Draft and execute qualification and validation documentation, including FDS/DQ, FAT, SAT, IQ and OQ.
• Coordinate quality assurance activities related to assigned projects.
• Collaborate on the planning and monitoring of qualification activities.
• Collect, analyze and agree with the client on validation requirements, ensuring compliance with internal standards and regulations.
• Participate in the execution of Factory Acceptance Tests (FAT) with the client.
• Execute SAT, IQ and OQ activities at the client's facilities.
• Drive continuous improvement of validation documentation and standards.
• Manage and supervise external qualifications, including protocol review and supplier monitoring.
• Provide support in the management and maintenance of documentation related to pharmaceutical regulations.
• Collaborate on the definition and monitoring of calibration plans for measuring instruments used during testing.
• Actively participate in continuous improvement initiatives for validation and quality processes.
Monday to Friday, 08/09h - 17/18h
1-2 remote work days
30 days of national and international travel
Ambit Iberia is a specialized consultancy providing IT and engineering services to the pharmaceutical and life sciences sectors, with a strong focus on regulated environments. The company supports clients with digital transformation, data integrity, and compliance-driven projects, offering services such as system validation, MES engineering, cybersecurity, and cloud-based software development. Operating primarily in Spain and Portugal, Ambit Iberia positions itself as a niche partner for pharma companies seeking technical expertise in highly regulated settings.
With its main office in Barcelona, Ambit Iberia serves as the Spanish arm of a broader international group, delivering projects across Europe. The company's work culture emphasizes technical excellence and regulatory compliance, making it an attractive option for international professionals with backgrounds in pharma IT, validation, and engineering. Many roles are offered as fully remote or hybrid, allowing flexibility for candidates based in Spain or Portugal, and the company actively seeks talent with experience in GxP environments and modern cloud technologies.