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CQV Lead Engineer - Commissioning & Qualification - Job Opportunity at Lonza

Stein, Switzerland
Full-time
Senior
Posted: August 1, 2025
On-site
CHF 120,000 - 160,000 per year (approximately USD 130,000 - 175,000). Swiss pharmaceutical sector compensation is typically 20-30% higher than other European markets, with Lonza as a major industry player offering competitive packages. Senior CQV roles in Switzerland command premium salaries due to the country's position as a global pharmaceutical hub and the specialized nature of commissioning and qualification expertise.

Benefits

Agile career development opportunities providing accelerated professional growth in a dynamic pharmaceutical manufacturing environment
Inclusive and ethical workplace culture fostering diversity and professional integrity
Performance-based compensation programs offering financial rewards tied to measurable achievements
Comprehensive lifestyle benefits package including family support and leisure activities
Relocation assistance for eligible candidates and their families, facilitating international career moves
Opportunity to work for a global leader in life sciences with operations across five continents

Key Responsibilities

Lead and manage a global team of CQV experts, driving strategic commissioning and qualification initiatives across multiple international sites
Oversee the development and execution of comprehensive protocols for life cycle documents, ensuring regulatory compliance and operational excellence
Direct commissioning and qualification planning and reporting processes, maintaining alignment with global pharmaceutical standards
Manage IV/IQ static testing execution across all site projects, ensuring consistent quality and compliance standards
Collaborate with cross-functional departments including engineering, manufacturing, quality, procurement and regulatory affairs to optimize CQ activities for cost efficiency and timeline acceleration
Oversee strategic remote office operations across multiple global locations to enhance operational efficiency and reduce project costs
Assess and manage supplier quality department capabilities to ensure timely delivery of compliant documentation
Lead CQV activities ensuring full compliance with regulatory requirements and industry standards while managing risk mitigation for CAPEX investments

Requirements

Education

Master Degree or equivalent experience in Pharma, Engineering, or Science

Experience

Proven experience in Pharma/Engineering (GEP/GMP) with understanding of Fill and Finish Facility Building and processes

Required Skills

Proven experience in Project Management CQV expertise Governance experience People management capabilities Proficient in English German language skills advantageous Understanding of Pharmaceutical/Bio Science Contract Manufacturing business Experience in cGM Strong leadership skills with global interaction capability Financial and commercial acumen with ability to link understanding to project goals, costs & scheduling, and risk Strong analytical skills for in-depth analysis of complex/large datasets, drawing conclusions and supporting decisions
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented growth in biologics and biosimilar manufacturing, driving demand for specialized CQV expertise in fill-and-finish operations. Contract Development and Manufacturing Organizations (CDMOs) like Lonza are expanding globally to meet increasing demand from pharmaceutical companies seeking to outsource manufacturing operations. Regulatory requirements are becoming increasingly stringent across global markets, particularly in the EU and US, requiring more sophisticated commissioning and qualification processes. The implementation of Industry 4.0 technologies and digitalization in pharmaceutical manufacturing is creating new challenges and opportunities in CQV processes. The shift toward personalized medicine and cell and gene therapies is driving need for more flexible and adaptable manufacturing facilities, requiring CQV leaders who can manage complex, multi-modal production environments. Global supply chain diversification post-COVID is leading to increased investment in pharmaceutical manufacturing capacity across multiple regions.

Role Significance

Likely managing 10-20+ CQV professionals across multiple global locations, with matrix management responsibilities extending to cross-functional teams including engineering, quality, and manufacturing personnel. The role involves coordination with external suppliers and regulatory bodies, expanding the effective team size significantly.
Senior leadership position with global scope and strategic impact. This role represents a significant step in CQV career progression, combining technical expertise with business acumen and international team management. The position influences major CAPEX decisions and regulatory compliance across multiple facilities, indicating high organizational trust and responsibility.

Key Projects

Global facility commissioning and qualification for new biologics manufacturing capabilities Technology transfer and scale-up projects for pharmaceutical and biotechnology clients Regulatory compliance initiatives for FDA, EMA, and other international regulatory bodies CAPEX optimization projects focusing on cost reduction and timeline acceleration Digital transformation initiatives implementing Industry 4.0 technologies in CQV processes

Success Factors

Deep understanding of global regulatory requirements and ability to navigate complex compliance landscapes across multiple jurisdictions. Success requires staying current with evolving regulatory guidance and building strong relationships with regulatory bodies. Strong leadership and communication skills to manage diverse, geographically distributed teams while maintaining consistent quality standards. Cultural sensitivity and adaptability are crucial for managing global operations effectively. Financial acumen and business understanding to optimize project costs and timelines while maintaining compliance and quality standards. Ability to make strategic decisions that balance technical requirements with commercial objectives. Technical expertise in modern pharmaceutical manufacturing technologies, particularly in biologics and fill-and-finish operations. Understanding of emerging technologies and their implications for CQV processes is increasingly important.

Market Demand

High demand driven by global pharmaceutical manufacturing expansion, particularly in biologics and specialty pharmaceuticals. The combination of regulatory complexity and technical specialization creates a competitive market for experienced CQV professionals, especially those with global team leadership experience and CDMO background.

Important Skills

Critical Skills

CQV expertise is absolutely essential as it forms the core technical foundation of the role. Deep understanding of commissioning and qualification processes, regulatory requirements, and industry standards is non-negotiable for success in this position. Global leadership and team management skills are critical given the international scope and remote team management requirements. Ability to inspire and coordinate diverse teams across different time zones and cultures directly impacts project success. Financial and commercial acumen is increasingly important in modern CQV roles, as technical leaders are expected to optimize costs and timelines while maintaining quality. Understanding of CAPEX management and ROI considerations is essential for strategic decision-making. Regulatory compliance expertise across multiple jurisdictions is crucial given the global nature of pharmaceutical manufacturing and the increasing complexity of regulatory requirements worldwide.

Beneficial Skills

German language skills would provide significant advantage given the Swiss location and European market focus, facilitating better communication with local teams and regulatory bodies Digital transformation and Industry 4.0 knowledge is becoming increasingly valuable as pharmaceutical manufacturing adopts new technologies for process monitoring, data management, and quality assurance Cell and gene therapy manufacturing experience would be highly beneficial given the rapid growth in this sector and Lonza's significant investments in these capabilities Lean manufacturing and continuous improvement methodologies would support the role's focus on efficiency optimization and cost reduction initiatives

Unique Aspects

Global scope with direct responsibility for multiple international locations, providing exceptional exposure to diverse regulatory environments and business practices
Strategic focus on cost optimization and efficiency improvement, combining technical expertise with business acumen in a way that's increasingly valuable in the competitive CDMO market
Leadership of remote office operations across strategic global locations, offering experience in distributed team management and international business development
Direct involvement in CAPEX investment decisions and risk assessment, providing valuable financial and strategic planning experience
Collaboration with external suppliers and assessment of their capabilities, developing valuable vendor management and quality assurance skills

Career Growth

Typical progression to executive roles occurs within 3-5 years for high performers, given the strategic nature of this position and the growing importance of CQV expertise in pharmaceutical manufacturing. The global scope and team leadership aspects of this role provide strong preparation for C-suite positions.

Potential Next Roles

Vice President of Global Quality or Engineering, overseeing broader organizational functions beyond CQV Chief Technology Officer or Chief Quality Officer roles in mid-size pharmaceutical or biotech companies Senior Director positions in large pharmaceutical companies managing global manufacturing operations Independent consulting roles serving multiple pharmaceutical and biotech clients Leadership positions in regulatory agencies or industry associations

Company Overview

Lonza

Lonza is one of the world's largest Contract Development and Manufacturing Organizations (CDMOs), specializing in pharmaceutical and biotechnology manufacturing services. The company operates across the entire pharmaceutical value chain, from drug discovery through commercial manufacturing, with particular strength in biologics and complex pharmaceutical products.

Lonza holds a leading position in the global CDMO market, competing with companies like Catalent, Thermo Fisher Scientific, and WuXi Biologics. The company's strong reputation for quality and regulatory compliance makes it a preferred partner for major pharmaceutical companies developing complex therapeutics.
Switzerland serves as Lonza's global headquarters and a major manufacturing hub, benefiting from the country's strong pharmaceutical ecosystem and regulatory environment. The Stein location is strategically positioned to serve European markets while maintaining global connectivity for international operations.
Lonza emphasizes scientific excellence and ethical business practices, with a culture that values innovation and collaborative problem-solving. The company's global presence creates opportunities for international exposure and career development, while its focus on life sciences provides meaningful work with direct impact on patient outcomes.
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