Validation Lead - RDT Engineering Excellence & Experience

F. Hoffmann-La Roche AG; Madrid; Presencial; EUR 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits package

Business travel opportunities

International collaboration

Descripción de la vacante

Roche is seeking a Senior IT Validation Professional to drive qualification across GxP computerized systems. You will design validation strategies, develop and approve validation plans, and ensure inspection readiness.

Your role includes auditing/test record reviews, risk assessments, and collaborating with diverse teams to maintain compliant, validated environments. Ideal candidates bring 6+ years in IT/software validation within pharma, strong knowledge of CSV/CSA and GAMP, and experience with

Formación

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field.
• 6+ years of IT & Software Validation (CSV/CSA, GAMP) in pharma environment.
• Experience authoring qualification deliverables, validation plans, reports, and registries.
• Familiarity with CSV regulations (FDA Part 11, Annex 11, EU GMP Annex 1).

Responsabilidades

• Define validation approaches and identify required deliverables for GxP computerized systems.
• Develop, approve validation/qualification plans and reports; review test plans and records.
• Provide testing consultancy on deviations and corrective actions.
• Lead investigations into deviations and root cause analyses.
• Prepare and support audits/inspections as CSV expert.
• Maintain validated state of systems and support periodic reviews.
• Propose process improvements and share validation knowledge.
• Collaborate with cross-functional teams in agile environments.

Conocimientos

Validation strategy

Documentation

Testing consultancy

Root cause analysis

Audit readiness

Cross-functional collaboration

English communication

Leadership

Educación

Bachelor’s degree in Computer Science, Engineering, Life Sciences

Herramientas

EDMS (Veeva)

ALM Tools (ServiceNow, JIRA)

Descripción del empleo

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position Job description

At Roche, compliance is our license to operate, and we are committed to delivering high-quality products. Every contribution you make will impact patients, as patient safety is at the forefront of everything we do. As a Senior IT Validation Professional, you will play a pivotal role in ensuring the quality of the products we deliver. You will be responsible for the evaluation, design, development, and approval of qualification deliverables, validation plans, protocols, and reports for computerized systems across various domains and product lines.

Description of the area The specific computerized systems related to this role are general purpose platforms for automation and application development. These platforms are used across Roche for a variety of GxP and non-GxP purposes.

• Validation / Qualification Strategy: Determine validation approaches and identify deliverables needed or impacted by projects, enhancements, or changes for GxP computerized systems.
• Documentation Review and Development: Review system documentation in accordance with Roche CSV SOPs and regulatory guidance. Develop and approve validation plans and reports; develop and approve qualification plans and reports; review and authorize test plans and reports, ensuring the system is ready to go live.
• Testing and Consultancy: Verify testing plans, activities, deliverables, and records. Provide consultancy on test-related deviations and corrective actions as per approved procedures.
• Deviation and Root Cause Analysis: Support investigations into deviations, identifying root causes, and defining corrective and preventive actions.
• Audit and Inspection Preparation: Act as a subject matter expert in CSV for system audit/inspection preparation and execution.
• System Maintenance: Ensure the validated state of systems is maintained, keeping them audit and inspection ready.
• Periodic Reviews: Lead and support system periodic reviews in accordance with company procedures.
• Continuous Improvement: Implement relevant frameworks and processes, propose and utilize tools, and prepare recommendations for process optimization.
• Training and Knowledge Sharing: Provide training and exchange validation/quality knowledge and experience.

Qualifications

Education: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.

Experience: Minimum 6+ years of experience in IT & Software Validation (CSV/CSA, GAMP) in pharma environment including: Leading validation / qualification for projects and system maintenance. Authoring qualification deliverables, validation plans, reports, and deliverable registries. Reviewing validation and testing-related deliverables, records, and other evidence, including relevant system documentation. Maintaining and supporting applications under global audit and inspection agencies.

Regulatory Knowledge: Very good knowledge of CSV regulations/guidance (e.g., CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices).

Tools: Experience in working with EDMS (i.e Veeva) and with ALM Tools (like ServiceNow, JIRA, or similar)

Risk Assessment: Strong expertise in system and data risk assessment.

Agile Methodology: Good understanding of Agile Methodology (Frameworks such as SAFe, Scrum); previous experience is an advantage.

Collaboration: Ability to work collaboratively in multiple cross-functional and agile teams to achieve milestones and goals.

Communication: Effective communicator with excellent verbal and written communication skills; proficiency in English is mandatory. Ability to communicate the relevance and detailed requirements of validation and qualification to non-experts.

Leadership and Soft Skills: Assertiveness, conflict management skills, leadership skills, and ability to work with diverse personalities and cultures.

Innovative Workplace: A workplace that supports and encourages innovation and new ideas.

Comprehensive Benefits

Attractive benefits and business travel opportunities.

Collaborative Environment

Work with international colleagues on exciting projects that shape the future of IT in healthcare.

Who we are A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.