Subject Matter Expert Process Validation & Life Cycle Management - Respiratory Orals & Small Mo[...]

Global Technical Operations & Supply

We are looking for a subject matter expert for process validation and technical maintenance activities, supporting industrialization, product technology transfer and life cycle management for Respiratory, Orals & Small Molecules products.

You will provide specialist technical support to R&D, Operations, Quality and external stakeholders, including contract manufacturers and subcontractors, ensuring robust and compliant manufacturing processes throughout the product lifecycle. As part of R&D Product Teams and the Extended Technical Team, you will support industrial process validation activities and coordinate technical maintenance on in‑market products, contributing to solutions aligned with Quality requirements and business needs.

You will be responsible for

• Participating in the technology transfer process between different Chiesi group sites (R&D included) and/or subcontractors operated by Global TechOP&S with a focus on process validation and all the propaedeutic activities.
• Collaborating in designing TT documents and matrix, supporting the identification of scientific rationales to be reported in quality and regulatory documentation.
• Finalizing the industrialization of new products within the R&D Product Teams (as a member of the Extended technical team) and structuring the industrial process validation.
• Executive responsibility for technology transfer activities between different Chiesi group sites, primary and secondary transfer, focusing on process validation.
• Scouting for new equipment/technologies and tools to improve manufacturing execution and process robustness.
• Being the key reference person for Global TechOP&S functions (including plant site process SME at Parma, Blois, Santana and Nerviano Virtual Plant) supporting technical expertise for maintenance activities for in‑market products, including maintenance needs collection, planning and execution, challenges identification, supporting geo‑expansion and module X maintenance.
• Being the key reference person in Global TechOP&S functions for product lifecycle, reporting to dedicated governance bodies.
• Supporting Chiesi functions (Global and Local) in preparation for audits (inspection readiness streams).
• Participating constructively or coordinating Extended Teams and work package development meetings (e.g., ETTs, Technical Maintenance, Operative Teams).
• Supporting the development and evolution of Chiesi products toward sustainability‑driven initiatives, engaging in eco‑friendly challenges and performing product sustainability assessment and defining improvement plans.
• Providing scientific evaluation and methodological support in problem solving, contributing to identifying root causes.
• Participating constructively in Extended Teams for task forces.

You will need to have

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• 5+ years in the pharmaceutical/biotech industry, with at least 3 years in a similar role or in manufacturing/technology and analytical quality/QC.
• Fluency in written and verbal English.
• Willingness to travel up to 30 %.

We would prefer for you to have

• Direct experience on respiratory products (DPI and/or pMDI) and/or oral solid and small molecules.
• Direct and solid experience in process validation and lifecycle management.
• Experience working in multicultural and multinational environments.
• Experience working within a CRO or CMO environment.

Technical Skills

• Demonstrated strength in problem‑solving and interpersonal communication, with proven ability to work effectively across technical, business and operational functions.
• Solid understanding of the pharmaceutical industry and end‑to‑end drug product manufacturing.
• Experience in pharmaceutical or biotech MSAT process development and/or GMP manufacturing.
• Strong working knowledge of current regulations, quality expectations and industry trends related to manufacturing and testing.

Soft Skills

• Ability to lead cross‑functional project teams in an international environment, including internal and external manufacturing (CMOs/CDMOs).
• Work and think proactively to support business continuity.
• Strong interpersonal skills and ability to interact with different stakeholders.

Location

The primary work location is Parma (Italy). The role offers flexibility, combining on‑site presence with remote work.

What we offer

We provide top‑class benefits, including comprehensive health care programs, work‑life balance initiatives, robust relocation support, a competitive salary package with basic salary, performance bonuses and benefits benchmarked against the external market. We also offer flexible working arrangements, remote work options and tax assistance services for foreign colleagues.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.