MSAT Validation Lead

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die Position

Principle Roles & Responsibilities / Accountabilities

Leadership

• Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward -thinking outlook; remove barriers,
• Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion.
• Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
• Contribute to a culture of continuous improvement and model lean leadership principles
• Contribute to a culture of transparent, high performance, empowerment and innovation culture.
• Acts as a mentor and coach to less experienced colleagues, providing guidance in mastering complex validation workflows, troubleshooting technical challenges, and developing skills in MSAT operations.

Technical

Engineering Project Support and Site Start Up Readiness:

• Participate in the design and construction of new facilities, including but not limited to manufacturing/cleaning process design, URS review, FAT, SAT, IOPQ, tech transfer and other aspects related to MSAT activities, thereby contributing to project delivery.
• Accountable for analysis of end-to end production process and facility capabilities to identify opportunities for improvement.
• Provides assessment of site capabilities with respect to new or modified processes
• Assesses product quality impact and root cause for significant process related investigations
• Maintain Process Validation and Cleaning validation status according to requirement of GSP, network SOP, and regulatory

Technical Expertise & Routine Operation:

• Serve as a Subject Matter Expert (SME) of process and/or cleaning validation: Develop and establish appropriate validation methods and validation plans. Lead initiate process and/or cleaning validation, re-validation, and periodic cleaning validation reviews.
• Implement process validation including creating protocol, sampling plan, training and report.
• Implement cleaning validation including creating protocol, sampling plan, training and report. By supporting the recovery rate from coupon materials to ensure the accuracy of sampling.
• Troubleshoot and resolve issues encountered during validation processes.
• Optimize cleaning to minimize contamination risks and enhance operational flexibility.
• Drive continuous improvement initiatives for SUT processes, with a focus on waste reduction, cycle time optimization, and sustainability.
• Support process equipment qualification as needed.
• Ensure all process and/or cleaning validation activities comply with GMP and relevant regulatory requirements.
• Participate in audits and regulatory inspections, providing expert knowledge and documentation on validation processes.
• Maintain a strong knowledge of regulations, especially those related to process and/or cleaning validation, equipment qualification.
• Work closely with internal teams and external stakeholders to facilitate smooth execution of validation projects.
• Provide training and guidance on validation best practices to team members and stakeholders.
• Other tasks assigned by the manager.

Qualification and Experience

Education/Qualifications

• Bachelor's Degree (Pharmaceutical / Biological is preferred) and above

Job Required Competencies

• 5 or more years process and/or cleaning validation experience, 8 or more years MSAT/Technical or qualification and validation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
• People management experience is a plus
• Prior experience in qualification and validation is advantageous
• Correlative Knowledge of validation
• Demonstrated experience in strategic thinking; highly skilled in negotiations, collaboration, and influencing
• Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification
• Experienced in new facility startup readiness and operation ramp
• Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
• Strong business acumen, communications, and analytical thinking required
• Strong interpersonal, leadership, collaboration and conflict resolution skills
• Experience leading major change initiatives strongly preferred
• Project management skills and Leading team capability preferred
• Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
• Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
• Knowledge of Quality management

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.