Site Process Engineer (Pharmaceuticals)

TL;DR

Site Process Engineer (Pharmaceuticals): Overseeing and optimizing pharmaceutical manufacturing processes for drug substances and products with an accent on GMP compliance and process robustness. Focus on supporting technology transfer, executing process validation (IQ/OQ/PQ), and implementing continuous improvement initiatives.

Location: Parma, Italy (Hybrid with 80% shopfloor presence). Relocation support is available.

Company

An international research-focused biopharmaceutical group with 90 years of experience operating in over 30 countries.

What you will do

• Manage and optimize pharmaceutical manufacturing processes for drug substances and drug products.
• Ensure strict compliance with GMP and regulatory standards such as FDA, EMA, and ICH.
• Lead process validation activities (IQ/OQ/PQ) and manage ongoing process verification (CPV).
• Support technology transfer from development to manufacturing sites from an engineering perspective.
• Investigate deviations and non-conformances to implement effective CAPA.
• Perform process risk assessments (FMEA) and develop control strategies.

Requirements

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, or a related field.
• 8+ years of experience in pharmaceutical manufacturing or process engineering.
• Deep knowledge of GMP and regulatory frameworks (FDA, EMA).
• Proven experience with process validation and manufacturing support.
• Strong proficiency in automation applied to pharmaceutical processes.

Nice to have

• Experience with biologics, sterile manufacturing, or API production.
• Certification in Lean Six Sigma (Green Belt preferred).
• Familiarity with Process Analytical Technology (PAT) and Quality by Design (QbD).
• Experience with digital systems including MES, SAP, and LIMS.

Culture & Benefits

• Comprehensive healthcare programs and work-life balance initiatives.
• Robust relocation support and tax assistance services for foreign colleagues.
• Competitive salary package including basic salary and performance bonuses.
• Flexible working arrangements and remote work options.
• Dynamic and friendly environment with access to continuous resources and training.