348025BR
Jul 13, 2022
Singapore

Job Description

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
• Planning, executing and reporting on Commissioning & Qualification for CAPEX projects
• Planning, performing and reporting routine manufacturing operation ensuring GxP compliance of plant/facilities/equipment
• Support internal and external audits
• Develop Project Schedule, perform project risk assessment, identify technical solutions, prepare project quality plan, develop project document management and archiving concept and Perform project reviews (e.g., Technical Quality Review (TQR), constructability, sustainability, HSE)
• Develop project execution plan (e.g., C&Q), Prepare / Execute Project Health & Safety Risk Assessments (Equipment / Process), Expedite and manage project vendors / contractors / 3rd parties in project, develop test specification / Plan for commissioning & Qualification in projects, perform new equipment FAT / SAT / inspections in project, execute work orders for projects as per method statement and Manage project deficiencies and deviations
• Plan initial calibrations, coordinate maintenance / calibration activities, Plan resources for maintenance / calibration, allocate work for maintenance / calibration to technicians, identify spare parts for maintenance and maintain pick‐lists, provide front line support for technicians, Assess quality impact and release after maintenance work and Investigate deviations (root cause analysis)
• Develop qualification plan, Perform GMP risk assessments (incl. Sensors SRA), Create DQ, IQ and OQ protocols, execute DQ, IQ and OQ, Create DQ, IQ and OQ reports, provide technical trouble shooting during PQ and validation, develop periodic requalification plan and execute periodic requalification plan

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• More than 5 years of experience in engineering project / commissioning / qualification / Compliance in Pharma
• Excellent technical knowledge with demonstrated ability to deliver safe, effective and fully compliant projects
• More than 5 years of demonstrated leadership abilities, leading external team members
• Excellent interdisciplinary knowledge (Lab Equipment, Process, HVAC, automation, etc.)
• Outstanding GxP and regulatory knowledge
• Advanced HSE knowledge

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!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO LARGE MOLECULES
Singapore
Singapore
Technical Operations
Full Time
Regular
No
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348025BR

Compliance & Qualification (C&Q) Engineer

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