Engineering Expert Pharmaceutical Equipment
2 mesi fa
In this role you will guarantee the operation in compliance of all the pharmaceutical end general equipment and systems present in Saluggia site (intended GMP compliance, Normative and Standard compliance, eCompliance) in order to satisfy necessary requirements of pharmaceutical processes and safety requirements, with particular attention to the Aseptic Processes.
**Work location**: Saluggia (TO)
**Your responsibilities include, but are not limited to**:
- Guarantee the correct operation of the equipment, systems, plants present in the production site through the coordination of all the Technical activities, carried out by external resources
- Coordinate the technical activities on the equipment as improvement projects and upgrade projects on the same ones
- Support the production activities participating in the multi-department workshops and projects
- Guarantee the Aseptic process compliance (by equipment upgrade) and Aseptic Process improvement
- Collaborate with MS&T and Production department to understand better their needs and processes for equipment compliance, efficiency, and reliability (evaluating needs for upgrade or substitution)
- Accountability for the GMP documentation both external and internal
- Improvement of the qualification, validation and other GMP / technical documentation adapting it to the corporate standards
- Execute qualification and validation activities or coordinate external resources in the execution under own accountability
- Support the process of Continuous Improvement and Compliance for aseptic processes and eCompliance improvement projects
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
**What you’ll bring to the role**:
- Master's degree in Engineering (Mechanical or Electrical is preferred)
- 4+ years of direct experience in Pharmaceutical companies or Consultant Companies for Pharmaceutical industry
- Direct Experience in managing pharmaceutical equipment (maintenance, calibration, requalification) **with particular attention to Aseptic processes** (sterilisation, depyrogenation, freeze drying, aseptic filling, WFI loops)
- Solid experience in preparation of the GMP documentation for pharmaceutical equipment
- Direct Experience in handling the projects for upgrade or substitution of the existing pharmaceutical equipment
- Direct experience in management (definition, follow-up) of budget for the equipment investments and coordination of external contractors and consultants
- Excellent team worker
- Fluent English and Italian, written and spoken
**Why Advanced Accelerator Applications?**
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis
**Imagine what you could do at Novartis**
**Join our Novartis Network**:
**Division**
Oncology
**Business Unit**
ADVANCED ACCELERATOR APPLICATIONS
**Country**
Italy
**Work Location**
Saluggia
**Company/Legal Entity**
AAA Italy Srl.
**Functional Area**
Technical Operations
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
Yes
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