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CSV & DI Officer - Job Opportunity at Thermo Fisher Scientific

Lengnau, Switzerland
Full-time
Mid-level
Posted: August 11, 2025
On-site
CHF 95,000 - CHF 120,000 per year (approximately USD 105,000 - USD 133,000). Switzerland offers premium compensation for pharmaceutical compliance roles, particularly in the Bern region where Thermo Fisher operates. The combination of CSV expertise, Data Integrity specialization, and leadership responsibilities commands higher salaries in the Swiss market compared to other European locations.

Benefits

Opportunity to work in a world-class GMP compliance environment with cutting-edge validation frameworks
Professional development through leading and mentoring staff across multiple departments
Global networking opportunities through participation in international Data Integrity initiatives
Career advancement potential in a Fortune 500 biotechnology leader
Inclusive workplace culture that values diverse experiences and perspectives
Mission-driven work environment focused on improving global health outcomes
Access to innovative scientific technologies and regulatory compliance methodologies

Key Responsibilities

Lead the strategic coordination of site-wide CSV framework and validation processes, ensuring operational excellence across all computerized systems
Design and maintain comprehensive GMP and Data Integrity training programs that elevate organizational compliance standards
Drive operational improvements through Data Integrity Gemba walks and champion mentoring, directly impacting manufacturing quality
Provide executive-level reporting on Data Integrity concerns and implement strategic mitigation plans aligned with site master objectives
Own and optimize site-wide Data Integrity KPIs, driving measurable improvements in compliance performance
Serve as organizational ambassador in global Data Integrity networks, influencing industry standards and best practices
Ensure regulatory compliance excellence for CSV activities while supporting critical regulatory submissions and inspection readiness

Requirements

Education

Degree in Information Technology, Engineering or Life Sciences (Biology, Chemistry, etc.), Dipl. lng. or M.Sc. or B.Sc. or equivalent

Experience

Proven experience in coordinating computerized systems validation (CSV) and data integrity in operations

Required Skills

Able to lead staff by example, providing technical support and mentoring Strong understanding of GMP regulations and validation practices Outstanding skills in training and mentoring staff on compliance frameworks Ability to strictly adhere to regulatory requirements and successfully implement necessary actions Excellent communication and collaboration skills to work effectively with cross-functional teams Self-motivated with a track record of contributing to regulatory submissions and inspections
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical and biotechnology industry is experiencing unprecedented regulatory scrutiny regarding data integrity, driven by increased FDA and EMA enforcement actions. Companies are investing heavily in computerized systems validation to avoid regulatory penalties that can reach hundreds of millions of dollars. The integration of digital technologies in manufacturing processes has created a critical need for CSV specialists who can navigate complex validation requirements while enabling digital transformation initiatives. Regulatory agencies worldwide are harmonizing data integrity expectations, creating standardized global frameworks that require specialized expertise. The ICH guidelines and FDA 21 CFR Part 11 compliance requirements are becoming more stringent, particularly for computerized systems in GMP environments. This regulatory evolution is driving demand for professionals who can implement robust validation frameworks while supporting business continuity. The pharmaceutical industry's shift toward continuous manufacturing and Industry 4.0 technologies is creating new validation challenges. Companies need CSV professionals who can validate complex integrated systems including cloud-based solutions, artificial intelligence applications, and real-time manufacturing execution systems. This technological evolution is expanding the scope and complexity of validation activities significantly.

Role Significance

Typically manages a team of 3-8 validation specialists and data integrity champions across different functional areas. The role involves matrix management of cross-functional teams including Engineering Quality, Manufacturing, Supply Chain, and Quality Control departments, potentially influencing 20-30 professionals indirectly.
This is a mid-to-senior level position with significant organizational impact and visibility. The role reports directly to site leadership and influences regulatory compliance across multiple operational areas. The position carries substantial responsibility for regulatory submissions and inspection readiness, indicating high organizational trust and accountability.

Key Projects

Implementation of comprehensive CSV frameworks for new manufacturing execution systems and laboratory information management systems Development and execution of data integrity remediation programs following regulatory inspections or internal audits Leading validation activities for facility expansions, new product introductions, and technology transfers between manufacturing sites Establishing digital transformation validation strategies for Industry 4.0 initiatives including cloud migration and AI implementation projects

Success Factors

Deep technical expertise in computerized systems validation combined with practical understanding of pharmaceutical manufacturing processes. Success requires the ability to translate complex regulatory requirements into actionable validation strategies that support business objectives while maintaining compliance integrity. Exceptional leadership and change management skills to drive organizational transformation in data integrity practices. The role requires influencing senior stakeholders across multiple departments while building consensus around compliance initiatives that may impact operational efficiency. Strong regulatory intelligence and industry networking capabilities to anticipate regulatory changes and implement proactive compliance strategies. Success depends on staying ahead of evolving regulatory expectations while maintaining cost-effective validation approaches. Strategic thinking ability to balance compliance requirements with business needs, optimizing validation efforts to support both regulatory obligations and operational excellence. This includes making risk-based decisions about validation scope and priorities.

Market Demand

High demand with limited qualified candidates. The specialized nature of CSV and Data Integrity expertise, combined with the regulatory complexity in pharmaceutical manufacturing, creates a significant talent shortage. Companies are actively competing for professionals with proven validation experience and leadership capabilities.

Important Skills

Critical Skills

GMP regulations and validation practices expertise is absolutely essential as this knowledge forms the foundation for all validation activities and regulatory compliance decisions. Without deep understanding of current GMP requirements and validation methodologies, the role cannot be performed effectively in the highly regulated pharmaceutical environment. Leadership and mentoring capabilities are critical for success as the role requires influencing and developing personnel across multiple departments without direct reporting relationships. The ability to drive organizational change through influence rather than authority is fundamental to achieving compliance objectives. Communication and collaboration skills are vital for coordinating complex validation activities across Engineering, Manufacturing, Quality Control, and Supply Chain functions. The role requires translating technical validation requirements into actionable plans for diverse stakeholder groups with varying technical backgrounds.

Beneficial Skills

Project management certification and experience would enhance effectiveness in coordinating large-scale validation initiatives and regulatory submissions across multiple functional areas and external vendors Industry 4.0 and digital transformation knowledge would provide competitive advantage as pharmaceutical companies increasingly implement cloud-based systems, artificial intelligence, and advanced manufacturing technologies requiring specialized validation approaches Regulatory intelligence and industry networking capabilities would enable proactive compliance strategies and early identification of emerging regulatory trends that could impact validation requirements and organizational planning

Unique Aspects

This role offers direct influence over global Data Integrity networks and industry standards, providing exceptional professional visibility and networking opportunities within the pharmaceutical compliance community
The position combines hands-on Gemba walking activities with strategic planning responsibilities, offering a unique blend of operational involvement and executive-level decision-making authority
Working at the Lengnau site provides exposure to Thermo Fisher's most advanced pharmaceutical manufacturing technologies and validation methodologies, accelerating professional development in emerging compliance areas
The role includes ownership of site-wide KPIs with direct reporting to senior leadership, creating accountability and visibility that accelerates career advancement opportunities

Career Growth

Career progression to director-level roles typically occurs within 3-5 years for high-performing CSV professionals, particularly in global pharmaceutical companies. The specialized nature of validation expertise and regulatory compliance experience accelerates advancement opportunities compared to other technical roles.

Potential Next Roles

Quality Assurance Director or Site Quality Head with broader responsibility for all GMP compliance activities across pharmaceutical manufacturing operations Global CSV Manager or Corporate Data Integrity Director leading validation strategies across multiple international manufacturing sites Regulatory Affairs Director specializing in CMC compliance and regulatory submissions for pharmaceutical products Digital Transformation Director focusing on Industry 4.0 implementation and validation in pharmaceutical manufacturing environments

Company Overview

Thermo Fisher Scientific

Thermo Fisher Scientific is a Fortune 500 biotechnology company and global leader in serving science with revenues exceeding $40 billion annually. The company operates across four primary segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services. With over 130,000 employees worldwide, Thermo Fisher serves customers in pharmaceutical, biotechnology, academic, government, and industrial markets.

Thermo Fisher Scientific holds the #1 market position in multiple segments of the life sciences industry, including laboratory equipment, consumables, and services. The company has established market leadership through strategic acquisitions and organic growth, creating comprehensive solutions for customers across the scientific research and healthcare continuum.
The Lengnau facility represents Thermo Fisher's significant investment in European pharmaceutical manufacturing capabilities. Switzerland serves as a strategic hub for the company's global operations, providing access to highly skilled talent and proximity to major pharmaceutical customers. The Swiss operations contribute to the company's global supply chain for critical pharmaceutical products and services.
Thermo Fisher Scientific promotes a mission-driven culture focused on enabling customers to make the world healthier, cleaner, and safer. The company emphasizes scientific excellence, innovation, and collaborative problem-solving. Employee development is prioritized through comprehensive training programs, global mobility opportunities, and involvement in cutting-edge scientific projects.
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