Main responsibilities and activities
In the Manufacturing Department we are looking for a brilliant profile reporting to the Site Production Head with the following responsibilities and activities:
Collects, interprets, analyzes and scientifically reports the data and information relating to the performance of the processes carried out in the production plants to assess whether they remain in a state of control in terms of cycle times, yields and costs.
Ensures and support continuous improvement task for manufacturing processes of commercial products.
Executes engineering tasks required by technological transfer of new products/processes from R&D or from other plants and by the implementation of new processes (scale-up, industrialization) for the optimization of existing production processes and for trouble-shooting, collecting and evaluating production results and drawing up technical reports/reports, where necessary.
Collaborates with MS&T in identifying operations and critical process parameters and provides technical contribution in operational standardization.
Collaborates with site functions in carrying out process validation and cleaning validation activities with constant supervision of field activities.
Actively participates by providing technical support to EHS assessments and contributes to the resolution of any identified gaps (for example HAZOP analysis of production processes, CAPA EHS, etc.).
Follows/executes technological tests in collaboration with MS&T or external technical companies, verifying the progress of the results and compliance with the programs.
Provides and/or collaborates in the development of the engineering documentation necessary for the definition of technical and functional specifications of new equipment and process lines (PFD, URS, etc.) or for modifications to existing ones, even with the help of process simulation software.
Supports and collaborates in complex investigations to identify the appropriate root case and establish the appropriate CAPAs.
Requirements
Main Requirements:
Quality Management Systems (GMP, GDP and Data Integrity standards) knowledge, to be applied in all work activities where these standards are required.
Knowledge and compliance with Environment, Health and Safety (EHS) regulations.
Respect for the Code of Ethics and company values.
Italian and English knowledge.
Education:
Bachelor Degree in Chemical Engineering or Industrial Chemistry.
Experience:
At least 3 year experience in chemistry / pharmaceutical chemistry industry (preferred GMP environment) or engineering companies.
