Site Process Engineer
Parma, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Global Technical Operations & Supply
Global Technical Operations & Supply (Global TechOp&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global TechOp&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.
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
What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
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