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Process Support Engineering Lead IFF (all genders) - Job Opportunity at Sanofi EU

Frankfurt am Main, Germany
Full-time
Senior
Posted: June 5, 2025
On-site
€90,000 - €120,000 annually, reflecting the senior leadership level, specialized pharmaceutical process engineering expertise, and the critical nature of this mega-project role within Germany's competitive biotech market

Benefits

Opportunity to lead high-impact mega projects with budgets exceeding €2 billion, positioning you at the forefront of pharmaceutical manufacturing innovation
Direct contribution to delivering 4.3 billion healthcare solutions annually, providing meaningful purpose and global impact in your daily work
Access to cutting-edge digital technologies and artificial intelligence initiatives, keeping you ahead of industry technological advancement curves
International career mobility opportunities with potential assignments in China and other global markets, expanding your professional network and cultural competencies
Comprehensive talent development programs with both vertical promotion and lateral movement options, ensuring continuous career progression aligned with personal goals
Recognition-based rewards package specifically designed to amplify individual contributions and acknowledge exceptional performance in high-stakes project environments

Key Responsibilities

Lead comprehensive process support engineering activities for a €200+ million design and engineering program, directly impacting the global insulin supply chain and patient access to life-saving diabetes medications
Orchestrate cross-functional collaboration with EHS, Operations, Quality, Procurement, and Legal teams to deliver optimized engineering solutions that balance regulatory compliance with cost-effectiveness and operational excellence
Manage and direct engineering contractors through complex deliverables including User Requirement Specifications, P&ID development, and functional analysis, ensuring on-time, full-scope delivery of critical project milestones
Establish and maintain project governance frameworks while building organizational capabilities that strengthen leadership effectiveness across internal and external teams
Implement comprehensive risk management strategies by identifying, assessing, and mitigating project risks through structured action planning and strategic communication with process leadership
Provide technical expertise during commissioning phases including Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), ensuring seamless transition from design to operational readiness

Requirements

Education

Master's degree in Chemical; Biotech Process Engineering or equivalent

Experience

Experience in Pharmaceutical Process Engineering Tier 1 project > 50 m€; Experience in managing Engineering contracts & facility start-up

Required Skills

In depth knowledge in Chemistry processes including aseptic technologies excellent problem solver and able to generate innovative a digital solution to improve efficiency collaborate effectively across the organization and build strong relationships to positively impact project results develop teams for future needs and translate business requirements into technical solutions English (Project language), Other languages will be appreciated
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented demand for insulin manufacturing capabilities driven by the global diabetes epidemic, with market projections indicating continued double-digit growth through 2030. This trend is particularly pronounced in emerging markets like China, where Sanofi's expansion strategy directly addresses growing patient populations and regulatory requirements for local manufacturing presence. Biologics License Application (BLA) processes are becoming increasingly complex and stringent, requiring specialized engineering expertise that combines deep technical knowledge with regulatory compliance understanding. Companies are investing heavily in engineering talent that can navigate both FDA and international regulatory frameworks while maintaining cost-effective manufacturing operations. Digital transformation and Industry 4.0 initiatives are reshaping pharmaceutical manufacturing engineering, with companies prioritizing professionals who can integrate traditional process engineering with advanced digital solutions, artificial intelligence, and automated systems to improve efficiency and compliance monitoring.

Role Significance

Typically manages teams of 8-15 direct and indirect reports including internal engineers, external contractors, and cross-functional stakeholders, with matrix management responsibilities extending across multiple departments and geographical locations
This is a senior leadership position requiring extensive process engineering expertise combined with project management capabilities, positioned as a critical decision-maker within Sanofi's global engineering organization with direct responsibility for multi-million euro project outcomes and cross-functional team leadership

Key Projects

Large-scale pharmaceutical manufacturing facility design and construction projects with budgets exceeding €50 million Biologics manufacturing process optimization and scale-up initiatives International manufacturing transfer projects requiring regulatory compliance across multiple jurisdictions Digital transformation initiatives integrating advanced process control and monitoring systems

Success Factors

Demonstrated ability to balance competing priorities between regulatory compliance, cost optimization, and timeline adherence while maintaining the highest quality standards required for life-saving pharmaceutical products Strong stakeholder management capabilities enabling effective collaboration across diverse teams including regulatory affairs, operations, quality assurance, procurement, and external engineering contractors with varying priorities and technical backgrounds Deep technical expertise in aseptic processing and chemistry applications combined with practical experience in large-scale manufacturing environments, particularly in biologics and insulin production processes Strategic risk management mindset with proven ability to anticipate potential project challenges, develop comprehensive mitigation strategies, and communicate effectively with senior leadership about project status and critical decisions

Market Demand

High demand driven by limited availability of senior process engineers with pharmaceutical manufacturing experience, particularly those with BLA regulatory knowledge and large-scale project leadership capabilities in the specialized insulin manufacturing sector

Important Skills

Critical Skills

Aseptic processing expertise is absolutely essential as insulin manufacturing requires sterile production environments with zero tolerance for contamination, making this knowledge critical for facility design, validation, and ongoing operations success. This skill directly impacts patient safety and regulatory compliance. Large-scale project management capabilities are crucial given the €200+ million engineering budget and complex stakeholder environment, requiring proven ability to coordinate multiple work streams, manage contractor relationships, and deliver on aggressive timelines while maintaining quality standards. Cross-functional collaboration skills are vital for success in this matrix organization environment where technical decisions must be balanced against regulatory, commercial, and operational requirements, requiring exceptional communication and relationship-building abilities across diverse teams and cultures.

Beneficial Skills

Digital solution development capabilities are increasingly valuable as pharmaceutical companies invest heavily in Industry 4.0 technologies, process automation, and data analytics to improve manufacturing efficiency and regulatory compliance monitoring Chinese market knowledge and Mandarin language skills would provide significant advantage given the specific focus on replication strategies for Glargine manufacturing in China, supporting career advancement in the growing Asian pharmaceutical market Regulatory affairs understanding beyond basic compliance, particularly with FDA, EMA, and NMPA requirements, would enhance effectiveness in facility design decisions and accelerate project approval processes

Unique Aspects

This role offers rare exposure to a mega-project with over €2 billion in capital expenditure, providing exceptional experience in large-scale pharmaceutical manufacturing project management that few professionals encounter in their careers
The position combines technical leadership with international scope, including specific focus on replication strategies for the Chinese market, offering valuable cross-cultural project management experience in one of the world's fastest-growing pharmaceutical markets
Direct involvement in BLA-compliant facility design provides specialized regulatory expertise that is highly valued and transferable across the pharmaceutical industry, particularly as biologics continue to represent the fastest-growing segment of pharmaceutical development
The role bridges traditional process engineering with digital innovation initiatives, positioning the successful candidate at the forefront of Industry 4.0 transformation in pharmaceutical manufacturing

Career Growth

Progression to director-level roles typically occurs within 3-5 years for high-performing senior managers, with VP-level opportunities emerging within 7-10 years for those who successfully deliver on large-scale projects and demonstrate consistent leadership effectiveness

Potential Next Roles

Global Engineering Director overseeing multiple manufacturing sites and project portfolios across different therapeutic areas Manufacturing Site Director with full P&L responsibility for large-scale pharmaceutical production facilities Vice President of Technical Operations with strategic oversight of manufacturing networks and capital investment decisions Chief Technology Officer roles within mid-sized pharmaceutical or biotechnology companies seeking experienced manufacturing leadership

Company Overview

Sanofi EU

Sanofi is a multinational pharmaceutical corporation headquartered in France, ranking among the world's top 5 pharmaceutical companies by revenue with over €40 billion in annual sales and a strong focus on immunology, diabetes, and rare diseases. The company operates in over 170 countries with approximately 100,000 employees globally, maintaining significant research and development investments and a robust pipeline of innovative therapies.

Sanofi holds a leading market position in diabetes care with established insulin brands including Lantus (glargine), commanding significant global market share and maintaining strong competitive positioning against major players like Novo Nordisk and Eli Lilly in the rapidly growing diabetes therapeutics market
The Frankfurt location represents Sanofi's significant European operations hub, providing access to the robust German pharmaceutical manufacturing ecosystem, skilled engineering talent pool, and strategic proximity to key regulatory bodies including EMA, while supporting the company's broader European manufacturing and distribution network
Sanofi emphasizes scientific innovation combined with operational excellence, fostering a collaborative environment that values diverse perspectives and cross-functional teamwork, with strong emphasis on patient impact and regulatory compliance, supported by comprehensive professional development programs and international mobility opportunities
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