MS&T Process Specialist - Caronno Pertusella (VA)

REPORTS TO: Site MS&T Head

JOB PURPOSE: Provide process chemistry support for the Caronno and Villanterio product portfolio, including the management of laboratory activities aligned with site-specific needs. Engage in core MS&T laboratory functions such as process robustness and optimization, process investigations, and technology transfer activities.

MAIN ACTIVITIES AND RESPONSIBILITIES:

• Performs chemical synthesis experiments and analytical studies i.e. to support investigations and troubleshooting; to synthetize impurities and standard, to qualify new suppliers as required.
• Performs chemical synthesis experiments for deficiency letter, carry-over studies and customer service support as required and writes the relevant technical documentation.
• Performs lab familiarization of existing manufacturing processes and collaborates in cross-functional projects to improve their robustness as well as scale-up, industrialization, process and cleaning validation, also performing modeling software designed scale down experiments.
• Performs lab familiarization and collaborates in process scale- up and technology transfer of either new product (from R&D) and / or existing commercial product (from TAPI Manufacturing Sites).
• Collaborates with production in identifying critical operations and gives technical contribution in operational standardization.
• Collaborates with engineering department in issuing equipment equivalency reports, also using software for process simulation and modelling.
• Oversees operations in production to guarantee standardization and reproducibility, especially in case of changes, CAPA implementations, and new productions.
• Strongly collaborates with production in order to collect process and production data (cycle times; yields) and standardize manufacturing floor operations.
• Strongly collaborates with production and Quality in case of deviations in production, investigations and CAPA identification.
• Participates in trainings to shop floor personnel.
• Collaborates with site functions in execution of Process Qualification, Process Validation and Cleaning Validation activities with on-field supervision.
• Finds and proposes solutions that can enhance current processes and productivity in manufacturing and collaborates with production in their implementation.
• Perform other duties as assigned or as business needs required.