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CSV & DI Officer - Job Opportunity at Thermo Fisher Scientific

Lengnau, Switzerland
Full-time
Senior
Posted: June 10, 2025
On-site
CHF 85,000 - 110,000 per year (approximately USD 93,000 - 120,000), reflecting the specialized nature of CSV expertise in Switzerland's high-value pharmaceutical sector and the premium associated with regulatory compliance roles in biotechnology companies.

Benefits

Opportunity to work with world-class compliance lifecycle approach in a leading biotechnology company
Access to comprehensive GMP and Data Integrity training programs
Professional development through mentoring and leadership responsibilities
Exposure to global Data Integrity networks and international initiatives
Career advancement in regulatory compliance within a Fortune 500 company
Inclusive work environment that values diverse experiences and perspectives
Contribution to groundbreaking scientific advancements with global patient impact

Key Responsibilities

Lead and coordinate the site's comprehensive CSV framework and processes, ensuring flawless validation activities that maintain regulatory compliance and operational excellence
Establish and maintain critical GMP and Data Integrity training programs that drive organizational compliance culture and regulatory readiness
Coordinate and participate in on-the-floor Data Integrity Gemba activities while providing strategic mentoring to DI champions across the organization
Ensure timely escalation and reporting of Data Integrity concerns to Site Leadership team while implementing mitigation actions based on approved Site Masterplan
Own and manage Data Integrity site KPIs, driving continuous improvement in compliance metrics and operational performance
Represent the Lengnau Site in global Data Integrity networks and initiatives, contributing to company-wide regulatory strategy
Ensure comprehensive regulatory compliance associated with CSV and contribute to regulatory submissions, responses, and inspections that impact market access

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

Proven experience in coordinating computerized systems validation (CSV) and data integrity in operations 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, with data integrity becoming a critical focus area for FDA, EMA, and other global regulatory bodies. Companies are investing heavily in robust CSV frameworks to avoid costly compliance failures and regulatory delays that can impact drug approvals and market access. Digital transformation in pharmaceutical manufacturing is driving increased complexity in computerized systems, creating higher demand for specialized CSV professionals who can navigate both technical validation requirements and regulatory compliance expectations. The shift toward continuous manufacturing and Industry 4.0 technologies in pharmaceutical production is creating new challenges for data integrity management, requiring professionals who can adapt traditional CSV approaches to modern digital manufacturing environments.

Role Significance

Typically manages a team of 3-8 validation specialists and coordinates with cross-functional teams spanning 15-25 professionals across Quality, Engineering, Manufacturing, and Supply Chain departments.
This is a senior-level position with significant organizational impact, evidenced by responsibilities for site-wide framework coordination, direct reporting to leadership, and representation in global networks. The role combines technical expertise with strategic leadership responsibilities.

Key Projects

Implementation of comprehensive CSV frameworks for new manufacturing systems and facility expansions Development and execution of data integrity remediation programs following regulatory inspections Integration of digital manufacturing technologies with existing validation and compliance frameworks Preparation and support for regulatory inspections and submissions that impact product approvals

Success Factors

Deep technical expertise in both computerized systems validation and data integrity principles, combined with the ability to translate complex regulatory requirements into practical operational procedures Strong leadership and change management capabilities to drive compliance culture transformation across diverse cross-functional teams Strategic thinking ability to anticipate regulatory trends and proactively adapt compliance frameworks to meet evolving industry standards Excellent stakeholder management skills to effectively communicate compliance requirements and risks to senior leadership while maintaining productive relationships with regulatory agencies

Market Demand

High demand driven by increasing regulatory complexity, digital transformation initiatives in pharmaceutical manufacturing, and the critical importance of data integrity in maintaining market access for pharmaceutical products.

Important Skills

Critical Skills

Computerized Systems Validation (CSV) expertise is absolutely essential as this represents the core technical competency required to ensure that manufacturing and laboratory systems meet regulatory requirements and maintain data integrity throughout their lifecycle. This skill directly impacts the company's ability to manufacture products that meet regulatory standards and avoid costly compliance failures. GMP regulations knowledge forms the foundation for all pharmaceutical manufacturing compliance activities, and deep understanding of these requirements is critical for ensuring that all systems and processes meet the stringent standards required for drug manufacturing and quality control operations. Data Integrity principles have become increasingly critical in pharmaceutical manufacturing due to heightened regulatory focus from global agencies, and expertise in this area is essential for maintaining regulatory compliance and avoiding enforcement actions that could impact product approvals and market access.

Beneficial Skills

Project management capabilities would significantly enhance effectiveness in coordinating complex validation activities across multiple departments and ensuring timely completion of regulatory compliance initiatives Risk assessment and management skills would provide valuable additional capability for identifying potential compliance vulnerabilities and developing proactive mitigation strategies Regulatory intelligence and trend analysis abilities would enable proactive adaptation of compliance frameworks to meet evolving regulatory expectations and industry best practices

Unique Aspects

Opportunity to work at the intersection of cutting-edge biotechnology and stringent regulatory compliance, contributing to products that directly impact global health outcomes
Access to Thermo Fisher's extensive global network of scientific expertise and advanced manufacturing technologies
Role combines strategic leadership responsibilities with hands-on technical work, providing comprehensive career development in regulatory compliance
Position offers exposure to both European and global regulatory frameworks, enhancing professional expertise in international compliance management

Career Growth

Progression to director-level roles typically occurs within 3-5 years for high-performing professionals, with opportunities for global leadership positions emerging within 5-7 years based on successful delivery of major compliance initiatives and regulatory inspection outcomes.

Potential Next Roles

Site Quality Director or Head of Quality Systems, overseeing comprehensive quality management across manufacturing operations Global CSV/Data Integrity Director, leading regulatory compliance strategy across multiple facilities and geographic regions Regulatory Affairs Director focusing on CMC (Chemistry, Manufacturing, and Controls) aspects of drug submissions Quality Systems Consultant, providing specialized expertise to pharmaceutical companies on validation and compliance frameworks

Company Overview

Thermo Fisher Scientific

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

Thermo Fisher Scientific holds a dominant market position as the world's largest supplier of scientific instrumentation and laboratory equipment, with significant competitive advantages in integrated solutions and global manufacturing capabilities that serve critical healthcare and research applications.
The Lengnau facility represents a strategic European manufacturing and development hub, supporting the company's significant presence in the European pharmaceutical market and serving as a key supplier for global drug development and manufacturing operations.
The company emphasizes a mission-driven culture focused on enabling customers to make the world healthier, cleaner, and safer, with strong emphasis on innovation, scientific excellence, and regulatory compliance that supports career development in highly regulated industries.
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