Qualification and CSV Technician

At Medinfar, your work has a real impact: helping to bring healthcare to everyone. Join a team driven by purpose, innovation, ethics and sustainability.

👉 Together, we take better care.

Your role at Medinfar:

The Qualification and CSV Technician plays a critical role in GMP operations by supporting the qualification of equipment, facilities, utilities and computerized systems in alignment with project, operational and quality objectives. This position works closely with Manufacturing, Engineering, Quality Assurance, IT and other key stakeholders to plan, execute and document validation/qualification and CSV activities. The role includes monitoring validated systems for facilities and utilities, developing and executing qualification and validation protocols / reports, authoring technical documentation and conducting investigations, as needed. The Technician applies regulatory requirements, data integrity principles and risk‑based methodologies to ensure the delivery of robust, compliant and high‑quality processes and systems.

How will you make a difference?

· Implement and maintain the Qualification, Validation and CSV documentation system, preparing procedures and lifecycle documents (e.g., VMPs, URS, RA, DQ/IQ/OQ/PQ protocols, System and Component Criticality Assessments), ensuring alignment with regulatory requirements (cGMP, ISO, ICH Q7, ISPE) and internal engineering standards.

· Review User Requirements Specifications (URS) and Functional Design Specifications (FDS) for new or modified equipment, facilities, utilities and computerized systems in collaboration with Production, Engineering, and Quality.

· Support and review the change control process, performing risk assessments and assessing the adequacy of validation requirements to ensure appropriate qualification and validation strategies.

· Prepare Validation Master Plans (VMPs) covering equipment, utilities, facilities and computerized systems.

· Coordinate System and Component Criticality Assessments in collaboration with Production, Engineering and Quality functions.

· Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) with Engineering, Maintenance and Operations to confirm acceptability of Process equipment.

· Prepare, execute and report all Qualification and Validation related activities (DQ, IQ, OQ and PQ) for Process equipment, utilities, facilities and computerized systems, ensuring they operate consistently and according to approved specifications.

· Troubleshoot and resolve issues identified during commissioning, qualification or validation, ensuring timely closure of open items.

· Ensure preparation and timely delivery of complete technical documentation packages, including engineering, qualification and CSV‑related documentation.

· Participate in the handover of commissioned and/or qualified equipment, facilities, utilities and systems to Production following completion of Engineering projects.

· Prepare and review Standard Operating Procedures (SOPs) related to qualification, validation and CSV activities.

· Review periodic cleanroom qualification and monitoring results in accordance with ISO 14644 and applicable regulatory requirements.

· Support deviation investigations and CAPA implementation, ensuring root cause analysis and corrective actions meet company and regulatory expectations.

· Supervise external validation contractors, ensuring timely and compliant execution of assigned activities.

· Participate in client, regulatory authority, and internal audits, providing subject‑matter expertise on qualification, validation and CSV processes.

What we are looking for:

• Degree in Engineering, Pharmaceutical Sciences or a closely related discipline is desired; alternatively, equivalent technical experience combined with demonstrated competence. A minimum of with a desired 3 to 5 years of Engineering and/or Operational experience in a GMP regulated environment is desired.

• Experience in developing commissioning, qualification, validation and risk management deliverables including specifications, protocols and reports that can withstand regulatory scrutiny.

• Strong interpersonal and communication skills, with the ability to collaborate effectively across multidisciplinary teams.

• Knowledge of quality and compliance principles, including regulations and standards applicable to GMP manufacturing.

• Ability to manage multiple projects simultaneously, demonstrating strong organizational and prioritization skills.

• Fluency in English, both written and spoken.

Why Medinfar?
Because here you will find more than just a professional challenge.
You will find purpose, impact, growth, and a team that believes that when we take care of each other, we take better care of everyone.

Help us build a better future for all.

👉 Together, we take better care.