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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in In Vitro Diagnostic (IVD) system validation, laboratory instrumentation management, and compliance with quality standards and regulations. Proficient in data analysis, technical report preparation, and collaborative problem-solving within multidisciplinary teams.
Highest-signal resume keywords
In Vitro Diagnostic (IVD) System ValidationLaboratory Instrumentation ManagementValidation And Verification Of Analytical MethodsRegulated Quality Systems ExperienceIntermediate English Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation And VerificationData AnalysisTechnical Report PreparationRisk AssessmentLaboratory Equipment CalibrationGood Laboratory Practices (GLP)Analytical MethodsQuality Standards ComplianceContinuous Improvement InitiativesTechnical Data Management
Soft Skills
Analytical ApproachOrganizational SkillsQuality-Oriented MindsetTeam CollaborationPriority Management
Tools & Technologies
Microsoft OfficeExcelSAP
Industry Keywords
Life SciencesBiologyPharmacyChemistryBiotechnologyDiagnosticsPharmaceuticals
About the role
Key responsibilities & impact- Ensure through validation activities and complementary studies that In Vitro Diagnostic (IVD) systems meet intended use and defined requirements.
- Participate in planning, execution, and documentation of IVD system validation activities.
- Collaborate in protocol development, data analysis, and preparation of technical validation reports.
- Support investigation and resolution of deviations, complaints, and root cause analyses.
- Contribute to corrective actions and continuous improvement initiatives.
- Evaluate design requirements, technical specifications, and risk assessments for compliance with quality standards and regulations.
- Participate in cross-functional projects and meetings supporting IVD system development, validation, and improvement.
- Manage laboratory instrumentation, reagents, and samples, ensuring availability, traceability, and maintenance.
- Ensure correct use, verification, calibration, and maintenance of laboratory equipment according to internal procedures and Good Laboratory Practices (GLP).
Requirements
What you’ll need- CFGS or Bachelor’s Degree in Life Sciences, preferably in Biology, Pharmacy, Chemistry, Biotechnology, or a related field.
- Proven experience of 1-2 years in laboratory environments, preferably within the diagnostics, biotechnology, or pharmaceutical sectors.
- Experience or knowledge in validation and verification of analytical, chemical, and/or biological methods.
- Experience or knowledge working within regulated quality systems.
- Intermediate English proficiency.
- Proficiency in Microsoft Office, particularly Excel.
- Ability to manage and analyze technical data.
- Basic SAP user skills.
- Previous experience in In Vitro Diagnostic (IVD) system validation, laboratory instrumentation management, and investigations related to deviations, incidents, or root cause analyses will be highly valued.
- Analytical, organized, and quality-oriented approach.
- Ability to work effectively in multidisciplinary teams, manage priorities, and contribute to continuous process improvement.
Benefits
Comp & perks- Flexible schedule: Monday-Thursday 8:00h – 17:00h and Friday 8:00h 15:00h.
- Benefits package
- Flexibility for U Program: 1 day remote working
- Permanent employment contract
- Equal employment opportunity and inclusive working environment
- Reasonable accommodations during the selection process