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!