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

TL;DR

Subject Matter Expert Process Validation & Life Cycle Management (Pharmaceuticals): Leading process validation and technical maintenance for respiratory and small molecule products with an accent on technology transfer and industrialization. Focus on ensuring GMP compliance, optimizing manufacturing robustness, and coordinating with CMOs to maintain product quality throughout the lifecycle.

Location: Parma, Italy (Hybrid)

Company

hirify.global is an international research-focused biopharmaceutical group and certified B Corp dedicated to promoting a healthier world through innovative drugs.

What you will do

• Act as SME for process validation and technical maintenance of respiratory, oral, and small molecule products.
• Coordinate technology transfers between group sites and external subcontractors (CMOs).
• Design TT documents and identify scientific rationales for regulatory documentation.
• Scout for new equipment and tools to improve manufacturing execution and process robustness.
• Support the evolution of products toward sustainability-driven initiatives.
• Provide scientific evaluation and methodological support for root cause problem solving.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or a related field.
• 5+ years of experience in pharmaceutical/biotech drug product manufacturing.
• At least 3 years of experience in a similar role or in Manufacturing/Technology/QC.
• Fluency in written and verbal English communication.
• Willingness to travel up to 30% based on project needs.

Nice to have

• Direct experience with respiratory products (DPI/pMDI) or oral solid/small molecules.
• Solid track record in Process Validation and Lifecycle Management.
• Experience in multicultural environments or within CRO/CMO settings.

Culture & Benefits

• Competitive salary package with performance bonuses.
• Comprehensive healthcare programs and work-life balance initiatives.
• Robust relocation support and tax assistance for foreign colleagues.
• Flexible working arrangements, including remote work options.
• Access to resources and training for professional development.