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Manufacturing Process Validation Specialist - Job Opportunity at Lonza

Visp, Switzerland
Full-time
Mid-level
Posted: August 4, 2025
On-site
CHF 95,000 - CHF 125,000 per year (approximately USD 105,000 - USD 138,000), reflecting Switzerland's premium compensation structure for specialized pharmaceutical roles and Lonza's position as a global leader requiring advanced technical expertise

Benefits

Comprehensive relocation package for eligible international talents, demonstrating strong commitment to global talent acquisition and employee mobility
Equal opportunity employment with diversity emphasis, providing inclusive workplace culture that enhances professional development and career advancement
Meaningful work with global impact on millions of lives, offering exceptional job satisfaction and purpose-driven career fulfillment
Career ownership philosophy allowing professional autonomy and innovation, enabling accelerated career progression and skill development

Key Responsibilities

Design comprehensive process validation strategies for biopharmaceutical manufacturing, directly impacting product quality and regulatory compliance across global operations
Lead preparation of critical validation documents including study designs, protocols, and reports, ensuring adherence to international regulatory standards and Lonza procedures
Provide strategic support to R&D teams during process characterization phases, bridging the gap between research innovation and commercial manufacturing excellence
Exercise approval authority for process characterization documents, demonstrating senior-level decision-making responsibility in manufacturing operations
Conduct validation assessments for manufacturing changes and deviations, maintaining product quality standards while enabling operational flexibility
Develop and maintain detailed continued process verification plans, ensuring long-term manufacturing consistency and regulatory compliance
Lead assessment and approval of Product Quality Reviews, providing strategic oversight of manufacturing performance and quality metrics

Requirements

Education

Master in Chemistry or equivalent experience, Biotechnology, Life Sciences or related field

Experience

Experience in project management, preferable in MSAT, Quality and Compliance

Required Skills

Experience in interaction with different collaborators within an organization and with regulatory agencies (Swiss medic, FDA etc.) First experience in mammalian Ability to work on different tasks simultaneously and to work towards deadlines Proficient communication in English (written and spoken) Additional proficient communication in German is appreciated
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Sauge AI Market Intelligence

Industry Trends

The biopharmaceutical manufacturing sector is experiencing unprecedented growth driven by increased demand for biologics and biosimilars, with process validation becoming increasingly critical as regulatory agencies intensify oversight of manufacturing quality systems. This trend is creating substantial demand for specialists who can navigate complex validation requirements while maintaining operational efficiency. Digital transformation in pharmaceutical manufacturing is revolutionizing process validation through advanced data analytics, real-time monitoring systems, and AI-driven quality assurance protocols. Professionals with experience in both traditional validation methods and emerging digital technologies are becoming highly sought after in the market. Regulatory harmonization across global markets is driving standardization of validation practices, with companies like Lonza requiring specialists who can manage multi-jurisdictional compliance requirements including FDA, EMA, and Swissmedic regulations simultaneously.

Role Significance

Typically leads cross-functional validation teams of 3-8 professionals including quality assurance specialists, manufacturing technicians, and regulatory affairs coordinators, while collaborating with broader MSAT teams of 15-25 members
Mid to senior-level specialist role with significant decision-making authority, evidenced by approval responsibilities for critical manufacturing documents and direct interaction with regulatory agencies, positioning the role as a key technical leader within the organization

Key Projects

Multi-million dollar biopharmaceutical product launches requiring comprehensive process validation packages and regulatory submissions Technology transfer projects moving products from development to commercial manufacturing scale with full validation documentation Continuous improvement initiatives optimizing manufacturing processes while maintaining validated state and regulatory compliance Regulatory inspection preparedness and response activities ensuring manufacturing site compliance with international standards

Success Factors

Deep understanding of ICH Q7, Q8, Q9, and Q10 guidelines combined with practical application experience in biologics manufacturing environments, enabling effective navigation of complex regulatory landscapes while maintaining operational efficiency Strong project management capabilities with ability to coordinate multiple validation activities simultaneously across different product lines and manufacturing scales, ensuring timeline adherence and resource optimization Excellent communication and stakeholder management skills for effective collaboration with R&D, manufacturing, quality assurance, and regulatory affairs teams while maintaining productive relationships with external regulatory agencies Analytical mindset with attention to detail for designing robust validation strategies that anticipate potential manufacturing challenges and regulatory scrutiny while supporting business objectives

Market Demand

High demand driven by rapid expansion of biologics manufacturing, increasing regulatory complexity, and shortage of qualified validation specialists with combined technical and regulatory expertise

Important Skills

Critical Skills

Process validation expertise in biologics manufacturing is absolutely essential as it directly impacts product quality, patient safety, and regulatory compliance. This skill set is increasingly rare in the market as it requires deep understanding of both manufacturing science and regulatory requirements, making professionals with this expertise highly valuable and difficult to replace. Regulatory agency interaction capabilities are crucial for success as this role involves direct communication with Swissmedic, FDA, and other regulatory bodies. The ability to effectively present validation data and respond to regulatory queries can significantly impact product approval timelines and manufacturing site compliance status. Project management skills are critical given the complex, multi-stakeholder nature of validation activities that must be coordinated across R&D, manufacturing, quality, and regulatory functions while meeting strict timelines and budget constraints.

Beneficial Skills

German language proficiency provides significant advantage in the Swiss pharmaceutical market and enhances career mobility within Lonza's European operations, particularly for roles requiring local regulatory interaction and team leadership Mammalian cell culture experience is increasingly valuable as the industry shifts toward more complex biologics and personalized medicine approaches requiring sophisticated manufacturing technologies and validation strategies Digital validation tools and data analytics capabilities are becoming essential as the industry adopts Industry 4.0 principles and regulatory agencies expect more sophisticated data analysis and real-time monitoring systems

Unique Aspects

Opportunity to work with cutting-edge mammalian cell culture technologies and next-generation biologics manufacturing processes, providing exposure to the most advanced techniques in biopharmaceutical production
Direct interaction with multiple regulatory agencies including Swissmedic and FDA, offering exceptional professional development in regulatory science and international compliance requirements
Role within Lonza's expanding biologics division provides exposure to high-growth market segments and emerging therapeutic modalities including cell and gene therapies
Strategic location in Visp offers unique combination of Swiss pharmaceutical excellence with access to European markets and regulatory frameworks

Career Growth

Typical progression to senior management roles within 4-6 years, with accelerated advancement possible given Lonza's global expansion and increasing complexity of biologics manufacturing portfolio

Potential Next Roles

Senior MSAT Manager overseeing multiple validation specialists and broader manufacturing science activities Regulatory Affairs Director focusing on global product registrations and manufacturing compliance Quality Assurance Director leading site-wide quality systems and validation programs Technical Operations Manager responsible for end-to-end manufacturing operations and process optimization

Company Overview

Lonza

Lonza stands as one of the world's leading contract development and manufacturing organizations (CDMOs) in the life sciences sector, with a strong focus on biologics manufacturing and a global footprint spanning five continents. The company serves as a critical partner to pharmaceutical and biotechnology companies, providing end-to-end services from early development through commercial manufacturing.

Global market leader in biologics CDMO services with significant competitive advantages in mammalian cell culture technology, regulatory expertise, and manufacturing scale capabilities, commanding premium pricing and attracting top-tier pharmaceutical partnerships
The Visp, Switzerland facility represents a strategic European manufacturing hub with direct access to both EU and Swiss regulatory frameworks, offering unique positioning for companies seeking dual-market manufacturing capabilities and regulatory expertise
Science-driven organization emphasizing innovation, quality excellence, and employee empowerment with strong focus on professional development and career advancement opportunities in a collaborative, multinational environment
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