Senior Global SME PV&LCM

TL;DR

Senior Global SME PV&LCM: Acting as a Subject Matter Expert for Process Validation and technical maintenance to support industrialization, technology transfer, and life cycle management for Respiratory, Orals & Small Molecules products with an accent on compliant manufacturing processes across the product lifecycle. Focus on executing and coordinating technology transfer and industrial process validation, leading problem-solving with root-cause evaluation, and serving as the key technical reference for global technical operations and supply.

Location: Parma (Italy) with flexibility combining on-site presence with remote work

Company

Chiesi is an international research-focused biopharmaceutical group developing and marketing innovative drugs across multiple therapeutic areas.

What you will do

• Act as Process Validation and technical maintenance Subject Matter Expert for industrialization, product technology transfer, and life cycle management.
• Participate in technology transfer between group sites and/or subcontractors, including propaedeutic activities and process validation documentation.
• Finalize industrialization of new products within R&D Product Teams and structure industrial process validation.
• Own executive responsibility for primary and secondary technology transfer activities with a focus on process validation and related propaedeutic work.
• Serve as key technical reference for Global TechOp&S functions (including plant site SMEs and virtual plant network) for in-market product maintenance needs, planning, execution, and challenge identification.
• Support audit readiness and contribute to sustainability-driven initiatives, including product sustainability assessment and improvement plans.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or a related field.
• 5+ years in pharmaceutical/biotech drug product manufacturing, with at least 3 years in a similar role or in Manufacturing/Technology and Analytical Quality/QC.
• English: fluency in written and verbal communication.
• Willingness to travel up to 30% (business trips may vary by project/business needs).
• Solid understanding of end-to-end drug product manufacturing and pharmaceutical industry quality expectations.

Nice to have

• Direct experience with 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/multinational environments and within a CRO/CMO environment.

Culture & Benefits

• Comprehensive healthcare programs and work-life balance initiatives.
• Flexible working arrangements with remote work options alongside on-site presence in Parma.
• Competitive salary package with basic salary, performance bonuses, and market-benchmarked benefits.
• Robust relocation support and tax assistance services for foreign colleagues.
• Training and development resources in a dynamic, friendly environment.

Hiring process

• Interviews to assess technical expertise in process validation, technology transfer, and lifecycle management.
• Evaluation of cross-functional collaboration and stakeholder management experience.
• Discussion of fit for global technical operations and supply responsibilities, including travel expectations.