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Cleaning Validation Engineer (MSAT) - Job Opportunity at Lonza

Visp, Switzerland
Full-time
Mid-level
Posted: August 4, 2025
On-site
CHF 85,000 - 110,000 annually (approximately USD 93,000 - 121,000), reflecting the specialized nature of cleaning validation expertise in the Swiss pharmaceutical sector, premium compensation for regulatory compliance roles, and Lonza's position as a leading global CDMO requiring competitive packages to attract international talent.

Benefits

Relocation assistance for eligible candidates and their families, providing comprehensive support for international talent acquisition and reducing the financial burden of career transitions
Career ownership opportunities that allow professionals to drive their own professional development and take initiative on meaningful projects
Global exposure working across three continents, offering extensive international experience and cross-cultural collaboration opportunities
Direct impact on millions of lives through products and services, providing intrinsic motivation and purpose-driven work environment
Equal opportunity employment ensuring fair treatment and diverse workplace culture that values all backgrounds and perspectives

Key Responsibilities

Design comprehensive cleaning validation strategies and develop critical regulatory documentation including study protocols and reports, directly impacting product safety and regulatory compliance across biopharmaceutical manufacturing
Lead high-stakes cleaning validation projects while maintaining direct customer relationships, ensuring project delivery excellence and strengthening client partnerships in the competitive biologics market
Provide technical oversight and approval authority for QC-led cleaning studies, establishing quality standards that protect product integrity and patient safety
Execute change management and deviation assessments with formal approval responsibilities, maintaining operational excellence while adapting to evolving manufacturing requirements
Deliver strategic oversight of cleaning validation across multiple manufacturing plants and product portfolios, ensuring enterprise-wide compliance and operational efficiency
Compile and present Periodic Cleaning Reviews to senior leadership and regulatory bodies, demonstrating ongoing compliance excellence and driving continuous improvement initiatives

Requirements

Education

A master's degree (or equivalent practical experience) in Chemistry, Biotechnology, Life Sciences, or a related discipline

Experience

Experience with project management, particularly in MSAT, Quality Assurance, or Compliance roles

Required Skills

Project management MSAT experience Quality Assurance Compliance Regulatory communication with bodies such as Swissmedic or the FDA Fluent proficiency in English (spoken and written) German language skills (highly valued) Strong organizational skills Ability to manage multiple priorities on deadline Collaborative mindset Excellent communication and interpersonal abilities
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Sauge AI Market Intelligence

Industry Trends

The biopharmaceutical industry is experiencing unprecedented growth driven by personalized medicine and biologics development, creating strong demand for specialized validation engineers who can ensure manufacturing compliance in increasingly complex production environments. Regulatory agencies are intensifying their focus on cleaning validation protocols, making expertise in this area critically important for maintaining market access and avoiding costly manufacturing delays. Digital transformation in pharmaceutical manufacturing is revolutionizing cleaning validation processes through implementation of automated systems, electronic batch records, and real-time monitoring technologies. This shift requires validation engineers to develop hybrid skill sets combining traditional validation expertise with digital fluency to optimize both compliance and operational efficiency. Global supply chain diversification in pharmaceuticals is driving companies to establish manufacturing facilities across multiple continents, creating opportunities for validation professionals with international regulatory experience and the ability to harmonize standards across different regulatory jurisdictions including FDA, EMA, and Swiss regulatory frameworks.

Role Significance

Typically leads cross-functional project teams of 5-8 members including QC analysts, manufacturing technicians, and regulatory affairs specialists, while collaborating with larger MSAT organizations of 15-25 professionals across multiple therapeutic areas and manufacturing sites.
Mid-to-senior level individual contributor role with significant autonomous decision-making authority, regulatory approval responsibilities, and direct customer interaction. The position carries substantial influence over manufacturing operations and regulatory compliance while requiring advanced technical expertise and project leadership capabilities.

Key Projects

Implementation of cleaning validation programs for new biologic product launches, involving development of product-specific cleaning protocols and qualification of cleaning procedures across multiple manufacturing suites Regulatory readiness initiatives for FDA and EMA inspections, including comprehensive cleaning validation documentation reviews and preparation of technical responses to regulatory inquiries Technology transfer projects supporting global manufacturing expansion, requiring harmonization of cleaning validation approaches across different regulatory jurisdictions and manufacturing sites Continuous improvement initiatives focused on optimizing cleaning procedures to reduce changeover times while maintaining compliance, directly impacting manufacturing efficiency and capacity utilization

Success Factors

Deep understanding of biopharmaceutical manufacturing processes and cleaning chemistry principles, enabling development of scientifically sound validation strategies that balance regulatory compliance with operational efficiency Strong regulatory acumen and ability to interpret evolving guidance documents from multiple health authorities, ensuring validation approaches remain current with changing regulatory expectations Exceptional project management capabilities with proven ability to coordinate complex validation studies involving multiple stakeholders while maintaining strict timelines and quality standards Advanced technical communication skills for presenting validation data to regulatory inspectors, senior management, and international customers in clear, defensible formats

Market Demand

High demand driven by expanding biologics manufacturing capacity, increasingly stringent regulatory requirements for cleaning validation, and limited talent pool with specialized MSAT cleaning validation expertise, particularly professionals capable of working across international regulatory frameworks.

Important Skills

Critical Skills

Regulatory compliance expertise is absolutely essential as cleaning validation directly impacts product quality and patient safety, with any deficiencies potentially resulting in regulatory citations, product recalls, or manufacturing shutdowns that could cost millions of dollars and damage company reputation Project management capabilities are crucial for coordinating complex validation studies involving multiple departments, tight timelines, and regulatory deadlines, with successful project delivery directly impacting product launch schedules and customer relationships Technical communication skills are vital for defending validation approaches to regulatory inspectors and presenting complex scientific data to diverse audiences including senior management, customers, and regulatory authorities

Beneficial Skills

German language proficiency enhances effectiveness in the Swiss workplace environment and facilitates communication with local regulatory authorities and European customers Digital systems familiarity supports the industry's ongoing digital transformation and enables more efficient validation data management and reporting Change management experience becomes increasingly valuable as pharmaceutical companies adapt to evolving regulatory requirements and implement new manufacturing technologies

Unique Aspects

Direct customer collaboration responsibilities uncommon for mid-level validation roles, providing exceptional exposure to commercial pharmaceutical operations and business development activities
Opportunity to work with cutting-edge biologics manufacturing technologies in one of Europe's most advanced pharmaceutical manufacturing facilities
Involvement in regulatory interactions with multiple health authorities including Swissmedic and FDA, offering valuable experience in international regulatory frameworks
Integration of cleaning validation expertise across multiple therapeutic areas and manufacturing platforms, providing broad exposure to diverse biopharmaceutical products

Career Growth

Career advancement to senior management roles typically occurs within 4-6 years with strong performance, given the specialized nature of cleaning validation expertise and growing demand for experienced professionals in expanding biologics manufacturing sector.

Potential Next Roles

Senior MSAT Manager overseeing multiple validation disciplines across biologics manufacturing operations Regulatory Affairs Director focusing on manufacturing compliance and CMC regulatory strategy Global Validation Lead managing cleaning validation programs across Lonza's international manufacturing network Principal Scientist role developing next-generation validation approaches and mentoring junior validation professionals

Company Overview

Lonza

Lonza operates as one of the world's largest contract development and manufacturing organizations (CDMOs) specializing in biologics, with extensive global manufacturing capabilities and a strong reputation for quality and regulatory compliance. The company serves major pharmaceutical and biotechnology clients worldwide, providing critical manufacturing services for life-saving therapies including cell and gene therapies, monoclonal antibodies, and other complex biologics.

Lonza holds a leading position in the global CDMO market with particular strength in biologics manufacturing, competing directly with companies like Catalent, WuXi Biologics, and Samsung Biologics. The company's Swiss operations represent some of the most advanced biopharmaceutical manufacturing facilities globally, setting industry standards for quality and regulatory compliance.
The Visp, Switzerland site serves as a major European manufacturing hub for Lonza's biologics operations, strategically positioned to serve both European and global markets while benefiting from Switzerland's strong regulatory environment and proximity to major pharmaceutical companies headquartered in Basel and other European locations.
Lonza emphasizes scientific excellence and collaborative innovation while maintaining rigorous quality standards essential for pharmaceutical manufacturing. The company culture promotes career ownership and professional development, with strong focus on employee empowerment and cross-functional collaboration in a highly regulated, detail-oriented environment.
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