Systems Validation Specialist

Your role mission will be provide support for validation activities and other complementary studies, ensuring compliance with applicable guidelines, procedures and regulations for IVD systems and the analytical laboratory.

This person will join the IVD (In Vitro Diagnostic) Systems Department within the Instruments Development & LCM (Life Cycle Management) Area at Diagnostic Grifols S.A. The department is responsible for validating instruments and their software, as well as participating in the proper integration of the different IVD systems (diagnostic instruments and associated reagents) used for blood group determination and antibody detection.

What your responsibilities will be

1. Perform IVD system validation activities:

• Participate in the planning, drafting and supervision of protocol execution; collaborate in obtaining and analyzing study data; participate in and contribute to the drafting of final validation reports for new products or product changes.
• Participate in the analysis of deviations identified during validations and identify corrective and improvement actions related to IVD systems.
• Participate in cross-functional/interdepartmental working meetings.

1. Perform IVD system activities:

• Participate in Root Cause investigation studies related to complaints concerning IVD systems.
• Participate in the analysis of design requirements and specifications to identify and determine critical aspects related to user actions.
• Participate in the review of IVD System Risk Analyses.

1. Management of assigned resources and tasks:

• Manage laboratory instrumentation using related applications (databases, repositories) and monitor compliance with verification, calibration and qualification activities.
• Manage reagents and samples (placing orders, stock control, expiration date monitoring).
• Ensure that laboratory instrumentation is used properly and responsibly.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• You have Bachelor's degree in Health Sciences (Biotechnology, Biochemistry, Pharmacy, Biology, Chemistry Engineering, etc) or FP/CFGS (Diagnostic, Clinical Laboratory, etc).
• Previous experience in a related field within the pharmaceutical sector will be considered an advantage.
• You haveknowledge in statistical analysis.
• You have working with MS Office, specially Excel.
• You have knowledge or experience with SAP or similar management software.
• You have intermediate level of English.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding. Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a Validation Specialist like you., It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.