Assc MSAT Manager - Validation Expert

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The Position

Job Summary

Overarch the site-level validation framework and define technical strategies for Process Validation (PV), Cleaning Validation (CV), and Test Method Validation (TMV).

Drive competence development within MSAT regarding validation methodologies, statistical tools, and standardized systems, demonstrating in-depth mastery of IVD reagent manufacturing processes (bulk compounding, formulation, lyophilization/freeze-drying, filling, etc.).

Provide authoritative technical consulting, risk rationales, and deep-dive troubleshooting for complex PV, CV, and TMV topics across the site.

Serve as the core Subject Matter Expert (SME) during internal and regulatory audits (e.g., NMPA, FDA, ISO).

Foster validation excellence and operational efficiency through Lean/Agile methodologies, statistical rigor, and digitalization tools.

Ensure ‘Right to Operate’ through full compliance with all applicable GMP, SHE, and other global and local regulatory requirements, as well as Roche Quality and SHE policies and standards.

Main Tasks & Responsibilities

Overarch and optimize site-level validation strategy documents; establish and maintain comprehensive Validation Master Plans (VMP) covering Process, Cleaning, and Test Method Validation.

Establish technical standards, validation rationales (e.g., family, matrixing, bracketing, worst-case evaluation criteria), and define lifecycle validation strategies .

Proficiently apply statistical tools to design, establish, and deploy scientifically sound sampling strategies.

Act as the senior validation technical interface connecting the site with global technical networks, ensuring dynamic scientific alignment and technical support.

Deliver high-level validation impact assessments, technical feasibility studies, and robust validation strategies for critical manufacturing changes (e.g., raw material localization/source changes, recipe sequence adjustments).

Lead root cause analyses and in-depth technical investigations for validation non-conformances, driving effective corrective and preventive actions.

Drive validation technical competence within MSAT; establish and standardize protocols, report templates, and sound scientific rationale frameworks across PV, CV, and TMV domains.

Lead or champion Continuous Improvement (CI) and Lean initiatives to eliminate process waste, streamline validation strategy, and enhance site operational performance.

Provide strategic validation support during new technology introductions and cross-site technical transfers, ensuring seamless cross-functional handover and flawless project delivery.

Ensure ‘Right to Operate’ through compliance with all global and local regulatory requirements applicable to RDSZ

Implement and apply the RDSZ Quality Management System (QMS)

Ensure all applicable SHE requirements been fulfilled to comply with corporate group policy and local regulations

Qualifications

Bachelor Degree in Pharmaceutical Engineering, Chemistry or Biology or equivalency. Preferred: Master Degree in Pharmaceutical Engineering, Chemistry or Biology or equivalency

Good command of written and spoken English

Above 6 years’ experience in a highly regulated cGMP manufacturing environment or equivalency

Related work experience in the Diagnostics, Pharmaceutical, Medical device Industry as Q&V engineer or expert.

Solid understanding of the QC/QM/Regulatory process

Reagent or liquid solution manufacturing process development experience.

Strong team oriented

High level attention to detail and strong analytical skills

Flexible and able to prioritize own work

Ability to work across functions within the organization/project

A “can-do” attitude and willingness to go the extra mile when required

Intercultural understanding and ability to work effectively with other nationalities

Achieving Results

Strong technical acumen

Strong communication and coordination skills

Strong continuous improvement expertise

Superior problem-solving skills with proven ability to anticipate issues and recommend effective and efficient solutions

 

 

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.