Spherical Search are currently seeking an experienced Head of New Product Introduction (NPI) Process Engineering to join their client, a integral, industry-leading manufacturer serving the pharmaceutical and biotechnology sector. With manufacturing operations across Europe, the USA, and Asia, this organisation is recognised for delivering high-quality, innovative solutions on a global scale.

Location: Ideally based in Belgium, Germany, Switzerland, or Italy. Belgium is the preferred location, as the majority of the engineering team is based there. Candidates located outside Belgium should be comfortable with frequent travel to support collaboration and leadership across the organisation - However they could work Hybrid or remotely depending on location.

Contract Duration: Initial 6-month contract, with a strong possibility of extension based on project requirements and performance.

Leadership Responsibility: Lead and develop a global team of 12 Process Engineering and Validation professionals, with the majority of the team based in Belgium. This role requires strong people leadership, cross-site collaboration, and the ability to drive alignment and execution across an international engineering organisation.

The Role

The Head of New Product Introduction (NPI) Process Engineering is accountable for the global leadership, strategy, and execution of New Product Introduction (NPI) process engineering and process validation within a GMP-regulated manufacturing environment.

This role is responsible for ensuring the successful industrialisation of new products through robust, compliant, and scalable end-to-end manufacturing processes while establishing best-in-class engineering and validation standards across multiple global manufacturing sites.

Key Responsibilities

Global NPI Engineering Strategy & Execution

- Define and execute the global NPI Process Engineering strategy aligned with business and product portfolio priorities.
- Ensure successful end-to-end industrialisation of new products, from development through to GMP samples.




- Drive on-time, right-first-time delivery of NPI projects across global sites, ensuring Design for Manufacturability and regulatory compliance.

Organisational Leadership

- Lead and develop a general team of NPI Engineering and Process Validation experts.
- Build organisational capability in process engineering, industrialisation, and validation excellence.
- Foster a high-performance, collaborative, and accountable culture.

Process Engineering & Industrialisation Excellence

- Design and implement robust, scalable, and cost-effective manufacturing processes.
- Oversee technology transfer and process qualification activities.
- Drive standardisation of engineering methodologies, tools, and technical solutions across all sites.

General Process Validation Governance

- Establish and maintain a harmonised, lifecycle-based validation framework across all manufacturing locations.
- Oversee the development and implementation of global validation SOPs, standards, and best practices.
- Ensure validation strategies are risk-based, efficient, and compliant with regulatory expectations.

GMP Compliance & Regulatory Readiness

- In collaboration with Quality, ensure all NPI engineering and validation activities comply with global GMP and regulatory requirements (FDA, EMA, ISO).
- Maintain inspection readiness and provide leadership during regulatory audits.
- Ensure alignment between product requirements, manufacturing capabilities, and quality standards.

Cross-Functional Leadership

- Act as the key interface between Product Lines, Quality, Operations, Supply Chain, and Commercial teams.




- Ensure seamless translation of product requirements into scalable manufacturing solutions.
- Align priorities, resources, and project execution across functions.

Portfolio & Project Governance

- Establish governance for project prioritisation, resource allocation, and execution tracking.
- Monitor performance through KPIs, including time-to-market, validation success rates, and cost adherence.
- Identify and mitigate project risks while ensuring proactive issue resolution.

Continuous Improvement & Innovation

- Drive the adoption of advanced engineering and validation approaches, including digitalisation, automation, and data analytics.
- Benchmark industry best practices and integrate them into internal engineering standards.

Lead initiatives to improve the efficiency, robustness, and scalability of NPI processes.

PFMEA Standardisation & Risk Management

- Establish and lead a global, standardised PFMEA framework for manufacturing processes.
- Define methodologies, scoring criteria, and governance for risk identification, assessment, and mitigation.
- Ensure consistent application of PFMEA across NPI projects and manufacturing sites.
- Integrate PFMEA with process design, validation strategy, and control plans.
- Lead cross-functional risk reviews and proactively mitigate critical process risks.

Candidate Profile

- Master's degree or PhD in Engineering, Chemistry, Materials Science, or a related discipline.
- 10–15+ years' experience in GMP manufacturing, New Product Introduction, Process Engineering, and Process Validation.
- Proven success leading global engineering organisations and complex industrialisation programmes.
- Deep expertise in process validation lifecycle management and regulatory frameworks, including FDA, EMA, and ICH.
- Strong leadership experience within matrix and multi-site manufacturing environments.
- Excellent strategic thinking, decision-making, stakeholder management, and communication skills.
- Fluent in English.

📌 Head of new product introduction (npi) process engineering (España)
🏢 Spherical Search
📍 España