Production Process Expert Biologicals

328619BR
Oct 08, 2021
Belgium

Job Description

5 products, in 3 years. That’s the speed at which we venture into biologicals. As Process Expert you provide front line expert support for all process-specific issues to production within compounding, filling and packaging activities. You ensure execution of processes and production deviation handling 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. Ownership for production related deviations
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 Implement 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.

Diversity & Inclusion / EEO

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

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/or quality
• Strong communication skills, digital and technological savviness, analytical and critical mindset.

Desirable requirements:
• Biological manufacturing experience
• Aseptic knowledge
• Certified investigator or deviation handling experience


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. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules, ...). Your office will be based in Puurs. Locally, we offer benefits to ensure our associate's mental and physical well-being. There is a fitness available for our associates to use and we offer a bike-leasing program. We have a mental coach on site as well.

Why consider Novartis?

769 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.

Imagine what you could do at Novartis!


Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

#LI-NOV
Novartis Technical Operations
NTO LARGE MOLECULES
Belgium
Puurs
Technical Operations
Full Time
Regular
No
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328619BR

Production Process Expert Biologicals

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