Subject Matter Expert Process Validation & Life Cycle Management - Respiratory Orals & Small Mol.

This is what you will do

You will act as 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 to 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 to structure the industrial Process validation
• Executive responsibility for Technology transfer activities between different Chiesi group sites (R&D included) and/or subcontractors operated by Global TechOP&S, both for primary and secondary technology transfer activities, with a focus on Process validation and all the propaedeutic activities
• Scouting for new equipment/technologies and tools to improve manufacturing execution and process robustness
• Being the key reference person for Global TechOP&S functions (incl. plant Site Process SME - Parma, Blois, Santana, Nerviano Virtual plant) supporting with technical expertise for maintenance activities for in-market products, regarding 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 to audits (inspection readiness streams)
• Partecipating constructively or coordinate Extended Teams and work packages development meetings (e.g., ETTs, Technical Maintenance, Operative Teams…)
• Supporting the development and evolution of Chiesi products toward sustainability-driven initiatives, through the Ecofriendly challenge and perform product Sustainability Assessment and define improvement plans
• Providing scientific evaluation and effective methodological support in problem solving, contributing in a significative way to identify root causes.
• Participating constructively to the Extended Teams for Task forces

You will need to have

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• 5+ pharmaceutical/biotech industry years in drug product manufacturing, with at least 3 years of experience in a similar role or in Manufacturing/Technology and Analytical Quality/QC area.
• Fluency in written and verbal communication in English.
• Willingness to travel up to 30%. Business trips may not be required at all times, travel frequency can vary depending on project/business needs.

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 activities.
• 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 a proven ability to work effectively across diverse technical, business, and operational functions.
• Solid understanding of the pharmaceutical industry and end‑to‑end drug products 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 in a proactive way 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.