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PROCESS EXPERT PACKAGING

PROCESS EXPERT PACKAGING
Job ID 280565BR
Position Title PROCESS EXPERT PACKAGING
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Job Description
4 products, in 2 years. That's the speed at which we venture into biotech. As Process Expert you provide front line expert support for all process-specific issues to production within packaging activities. You ensure execution of processes on-time and continuously improving in quality and productivity.
Embrace the future of the Biological organization and join the team.
Your responsibilities:
Your responsibilities include, but are not limited to:
* Stewardship:
o Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
o Responsible for maintaining the master manufacturing documents of assigned products
o Ensure that all critical parameters are within written Instruction
o Support Product steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
o Ensure that all process changes in assigned products are managed through appropriate change control procedure.
o Ensure creation of production procedures
o Act as Subject Matter Expert (SME) for the product and process knowledge,
o Collect data for ongoing process verification, support product steward in tracking and evaluation of product performance and implementation of CAPAs.
o Perform first line evaluation of product and process related issues
o Maintain processes at inspection readiness level.
o Support process optimization establishment and new technology introduction
* Validation:
o review validation protocols and support the execution of process validations
o Short-term improvement projects: liaising with all the relevant parties on the shop floor to ensure accurate execution.
* Launch & Transfer:
o Responsible for creating the master manufacturing documents of assigned products
o Be knowledgeable of process design by providing input during process transfer.
* Manufacturing Excellence:
o Execute process improvements and scale-up.
o Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables.
* Training: Support technology trainings and education programs for production operators.

Minimum requirements
What you'll bring to the role:
Your responsibilities include, but are not limited to:
* Education in a scientific field (Bio engineering, Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology,...)
* Fluent in Dutch and good knowledge of English
* +3 years' experience in process support on the shop floor of GMP pharma manufacturing
* Proven process understanding (Pharma, GMP, Regulatory aspects) and/or experience in fields as validation and quality
* Strong communication skills, startup mindset, analytical and critical mindset.
Desirable requirements:
* Biotech experience
* Aseptic knowledge
You'll receive:
We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Your office will be based in Puurs. Novartis supports a flexible work-life integration.
Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
#LI-NOV
Division Novartis Technical Operations
Business Unit NTO ASEPTICS
Location Belgium
Site Puurs
Company/Legal Entity ALCON BEL
Functional Area Technical Operations
Job Type Full Time
Employment Type Regular

PROCESS EXPERT PACKAGING

Novartis, Puurs
Permanent contract
Production Engineer, Process Engineer