Site Process Engineer

This is what you will do

We are seeking a skilled Process Engineer to oversee and optimize pharmaceutical manufacturing processes. This role is responsible for ensuring process efficiency, robustness, and compliance with GMP and regulatory standards, while supporting production, technology transfer, and continuous improvement initiatives.

You will be responsible for

• Managing and optimizing pharmaceutical manufacturing processes (drug substance and/or drug product)
• Ensuring compliance with GMP (Good Manufacturing Practices) and regulatory requirements (e.g., FDA, EMA, ICH)
• Supporting process validation activities (IQ/OQ/PQ) and ongoing process verification (CPV)
• Supporting technology transfer from development to manufacturing sites engineering point of view
• Monitoring process performance using data analysis and implement improvements
• Investigating deviations, non-conformances, and implement CAPA (Corrective and Preventive Actions)
• Collaborating with cross-functional teams including Manufacturing, Quality Assurance, Validation, and HSE
• Contributing to process risk assessments (e.g., FMEA) and control strategies
• Supporting audits and regulatory inspections
• Driving/Supporting continuous improvement initiatives
• Ensuring proper documentation in line with GMP standards

You will need to have

• Bachelor’s or master’s degree in chemical engineering, Pharmaceutical Engineering, or related field
• 8+ years of experience in pharmaceutical manufacturing or process engineering
• Strong knowledge of GMP and regulatory frameworks (FDA, EMA)
• Experience with process validation and manufacturing support
• Good understanding of data analysis and process monitoring tools
• Strong problem-solving and organizational skills
• Strong knowledge in automation applied to pharmaceutical process

We would prefer for you 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 (e.g., MES, SAP, LIMS)
• Exposure to technology transfer projects 

Key Skills

• Process optimization and troubleshooting
• Data analysis and statistical thinking
• Regulatory compliance and documentation
• Cross-functional collaboration
• Time and project management
• Communication and stakeholder management 

Work Environment

• Combination of office and GMP production environments (80% shopfloor)
• Close interaction with manufacturing and quality teams
• May require occasional travel to supplier
• Dynamic and regulated environment with high quality standards

Location

Parma