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Site process engineer

Experteer Italy

Experteer Overview In this role you will optimize pharmaceutical manufacturing processes to ensure efficiency, robustness and GMP/regulatory compliance. You will support production, technology transfer and continuous improvement within Global Tech Ops & Supply. You will analyze process data, drive improvements, and ensure compliant documentation and CAPA closure. This role offers the chance to contribute to end-to-end manufacturing and process validation in a global, quality-driven environment. Retribuzione / Benefits Manage and optimize pharmaceutical manufacturing processes (drug substance and/or drug product) Ensure compliance with GMP and regulatory requirements (FDA, EMA, ICH) Support process validation activities (IQ/OQ/PQ) and ongoing CPV Assist technology transfer from development to manufacturing from an engineering perspective Monitor process performance using data analysis and implement improvements Investigate deviations and non-conformances; implement CAPA Collaborate with cross-functional teams (Manufacturing, Quality Assurance, Validation, HSE) Contribute to process risk assessments (FMEA) and control strategies Support audits and regulatory inspections Drive and support continuous improvement initiatives Ensure proper GMP-compliant documentation Responsabilità 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 Requisiti fondamentali comprehensive healthcare programs work-life balance initiatives relocation support competitive salary with performance bonuses flexible working arrangements remote work options #J-18808-Ljbffr

Offerta di lavoro pubblicata 2 mesi fa