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Npi Process Expert/engineer
2 weeks ago
More than 380 That’s the number of associates in our Singapore Large Molecules division to support the making of medicines for our patients worldwide.**Key Responsibilities**
- Involved in the interface with Technical Operations team and Tech transfer team, for the corresponding global activities, to define and implement new technical transfer for existing and new technologies and equipment.
- Owns the knowledge of specific pharmaceutical manufacturing process technologies and processes related to new product introductions (eg. DFFA, SSPD, BOM, QRA, Quality/Validation Requirements setup)
- Participate in the definition and selection of pharmaceutical equipment and necessary process modifications (e.g. CAPEX projects), through providing input as User Requirements.
- Collaborate with technical development, other sites and MS&T network and cross-functional team to facilitate transfer of and implementation of technical knowledge.
- Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates by closely supporting n-GMP/GMP/Process validation batches
- Support in developing process test specification, automation recipes; FAT, generate master batch records, sampling SOP, column packing and update relevant SOP’s and support CAPEX, production takt time, product changeover discussions
- Build quality into the processes from design and having mindset of cost leadership and efficiency. Transfer of information and increase awareness of production teams following problems or modifications having a technical, quality or HSE impact.
- Coordinate and ensure the completion of all NPI project on time, in accordance with the documentation and in compliance with GMP, HSE and 5S rules. Also, coordinate and support the completion of commissioning, qualification and validation activities when/where needed.
**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**
- University degree in Engineering
- Minimum 3 to 5 years' experience in GMP manufacturing relevant to the specialist area of expertise
- Preferably prior experience with new product introductions in manufacturing/Engineering/MSAT role
- Good understanding or capacity to quickly understand production processes
- Pharma or Engineering industry background will be an added advantage
- Good scientific and technical (automation) understanding
- Able to work flexible hours
**Why consider Novartis?**
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking 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 at Novartis**
**Division**
- Novartis Technical Operations
**Business Unit**
- CONTRACT MANUFACTURING
**Country**
- Singapore
**Work Location**
- Singapore
**Company/Legal Entity**
- NOV SINGAPORE PHARMA MANUFG
**Functional Area**
- Technical Operations
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No