Engineer Project Manager
Resume:
Address:
Benedini ing. PierLuigi
via Vasco de Gama n 6
*********.********@*******.**
phone: 045-*******
Cell 348-***-**-**
Brief Presentation
I'm actually working in the Research & Development in the Process Technology and Pilot Plant Unit. I work now in Chemical Pilot Plant as technical responsible. I optimise the processes that come from the labs; I collaborate with the process owner to define the critical control to be put in place and the acceptable operational and control space. I have experience in the Industry manly in production as Process and Equipment Engineer with the responsibility of Validation and Tests activities. I worked in the Engineering Department and I was in charge of process and equipment improvements and optimisation for two sites, in Verona and in Parma, north of Italy. I have a wide experience with major processing technologies used in Industrial business. I optimised Sterilisation cycles; I worked for a new device development, a mono-use nasal spray, with an international team. I was the trade union between R&D and the production site. I have the Chemical Engineer Degree with professional grant.
CURRICULUM VITAE
Process and Plant Engineer from 2003 to now
In GlaxoSmithKline Research & Development
I’m now the Process & Plant Engineer in the Process Technology & Pilot Plant Unit. I lead the Plant Changes and the Scale Up activities within the Research Project Team. The Pilot Plant produces chemicals to support the research activities, mainly from Candidate Selection to POC. We work in a team, High Performance Team, which is responsible to delivery the active to support the product development. I’m in charge to define and install the PAT technology and test them in new processes. Last years we scale-up six new chemical entity and we used: Lasentec, MonArc, Brucker to monitor the process. I installed two new Filter Dryers, a centrifuge and new reactors. I ensure timely execution of project plans and tray to identify potential bottlenecks. I know the global R&D process and I have a project management background. I lead the Plant Changes and the Maintenance activities. The Pilot Plant produces chemical products to support the research activities, test on animals or clinical trials. AIFA has granted the approval of the site for the production of API in a multipurpose plant. I’m responsible of all Validation Phases, from User Requirements Specification (URS) to Performance Qualification (PQ) including Quality and Environmental Health & Safety verification. I work with EHS and Quality functions to verify the department compliance with law requirements.
Page. 2 of 3
Process Technology Engineer from 1998 to 2003
In GlaxoWellcome Engineering Directorate - Global Manufacturing Supplier
Between 1998 and 2003 I worked in the Engineering Dept’ and I was in charge of the Process Technology Unit made by 3 people. Aim was to implement Process Technology in production lines. The Unit worked for GSK Verona and Parma sites, focusing on optimization of secondary production processes and packaging machines. My team was covering projects from the approval of User Requirements Specification (URS) up to Performance Qualification (PQ) and first production trials. All lines were successfully approved by Regulatory Authorities (FDA and AIFA). I was directly responsible Validation Activities.
Below are listed some projects led directly by me in this timeframe:
- Refurbishment of vial filling line 3 with new presentation
(MonoVial for the European Market) 1998 - Refurbishment of vial filling line 2 1999 - Vial & ampoules inspection machine Parma 1999 - Refurbishment of vial filling line 3 with new presentation
(ADD-VANTAGE for the USA Market) 2000 - Refurbishment of vial filling line 1 1999
- Refurbishment of vial filling line 4 1999
- Process technology Optimisation 2000
- Packaging Line for Japanese market (inspection machine) 2000
- Freeze Drying dept. 2001
- Intraject Project 2002
- Group Sterile Forum 2003
- Sourcing Group Activities 2003
- Tablet Inspection for Japanese Market 2003
Process & Product Engineer from 1991 to 1998
Glaxo Product Development Directorate - Global Manufacturing Supplier
From 1991 to the end of 1998 I worked mainly for GSK Parma Site, production site for new products introduction.
I was based in Verona but I spent more than half of my time in Parma.
Here below there is the projects list I worked for with the role of Process & Product Engineer.
- New ampoules dept Glaxo Parma 1991 - New syringes dept Glaxo Parma 1992 - Development of a new Nasal Spray device
And technology transfer from Research 1992
- Nasal Spray dept Glaxo Parma 1994
- Nasal Spray Packaging Line 1994
- Basic Design for Doubling the Nasal Spray Dept. 1995
Process Engineer from 1988 to 1991
Glaxo Verona Project Directorate - Manufacturing Supplier
I started to work for Glaxo Company in 1988 in the Project Directorate. I was in charge of new projects and I started with the installation of an environmental monitoring system in a Tablet Department. I also validated the Department.
List of main projects:
- Tablet Department Validation 1988 - Tablet Monitoring System 1989 - Research Building Commissioning
and Validation 1989
Page. 3 of 3
- Tablet Department Validation 1990 - Sterile Vial Filling Machine Improvements 1990 - Packaging line Improvements 1991
Project Engineer from 1985 to 1988
Fidia Pharmaceutical - Site Directorate
After a short experience in the University I have been engaged by an Italian Pharmaceutical Company, FIDIA FARMACEUTICI. I worked in the Site Industrial Department and I was in charge of the Secondary Production Technical Operation, New Projects and Process Optimisation.
List of main activities I followed:
- Injectable Department Validation 1985 - Water for Injection new plant 1985 - New Injectable dept 1985 - New Ointment dept. 1985 - Freeze Drying dept. 1986 - New packaging dept 1986 - New packaging line 1987
The production was inspected and approved by FDA and MCA.
Training: - Water in the Industry (MI) - Powders-Their Properties & Processing (Amsterdam) - Warehouse in the Pharmaceutical Industry - Pneumatic Conveying for Bulk solids (Amsterdaam) - Design of Pharmaceutical Department - Environment Pollution: The New Laws (Roma) - Meeting Management - Project Manager Development - Finance and Economy Basic Rules - Pollution Laws and Authority - Pharmaceutical Good Manufacturing Practices for
Engineering Services - Pharmaceutical Processing - Information Technology Windows Office - Training for FDA Inspection - International conference and training on
Thermal sterilisation - ISO 14001 - “On line print workshop” - Sterile Production “Equipment and Technology forum” - Meeting Presentation
- Japan and the Japanese
- LEAN & SIX SIGMA - Fire Risk & ATEX - HAZOP
- Risk Assessment - cGMP periodic refresh training - EHS periodic refresh training
- Information Technology MS Project
- Information Technology AutoCAD
- Audit Management
Personal Features
I was born in Verona 7 June 1960. I’m married with three children.
I likes the country life and to play basket ball.
Contact this candidate