Process Cleaning Validation Engineer Monza

Process Cleaning Validation Engineer
Monza
Lombardia, Monza

My client is currently looking for an experienced Process Cleaning Validation Engineer with a background in Pharma and knowledge of tech transfers.

Role - Process Cleaning Validation Specialist Location – Monza, Italy Length of contract - 12 Months ( Extension) Description Working in close contact with Clients' quality teams to develop a robust validation strategy in accordance with Client's expectations and requirements; Reviewing Process and Cleaning Validation protocols and reports for clinical, registration and validation batches manufacturing, in accordance with GMP and corporate standards; Providing Qualitative and Technical recommendations to permit plant operation within regulatory requirements (FDA, EMEA, AIFA, etc.

); Supporting in drawing manufacturing instructions (MBR) or cleaning procedures (SOP) which need to be validated; Supporting the quality evaluation of process design features and filter validation aspects; Ensuring that new product introduction and all process changes are adequately evaluated and managed through change control management; Supporting the preparation and participation to Clients' and Regulatory audits with regards to validation activities.

Requirements Solid technical background in engineering, chemical engineering, pharmacy, or similar fields.

Minimum of 5-10 years of operational experience in cleaning validation of equipment, facilities, or processes within the pharmaceutical and life science industries.

Knowledge of basic sterility assurance concepts; Knowledge of basic analytical methods (chemical and microbiological); Looking forward to speaking with you!