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PROCESS EXPERT PACKAGING

Ref: 58432

Six days ago
Job Location
Puurs

Introduction

Embrace the future of the Biological organization and join the team.

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.

Company/Department

Alcon is een internationaal topbedrijf in de oogheelkundige sector en is genoteerd op de beurs van New York. Novartis is sinds kort de hoofdaandeelhouder. Alcon is gespecialiseerd in geneeskundige toepassingen voor de verzorging van het oog. De kwaliteit van onze productieprocessen en dienstverlening staat hoog aangeschreven. Daarboven investeert Alcon meer in oftamologisch onderzoek en ontwikkeling dan eender welke onderneming in de wereld. Momenteel worden de producten verkocht in meer dan 180 landen. De divisie in Puurs vervaardigt gebruiksklare steriele oogdruppels, oogzalven en injectievloeistoffen. Binnen het bedrijf is er ook de Custom Pak-fabriek. Deze fabriek is uniek in Belgie. Custom Paks zijn steriele pakketten die medische hulpmiddelen bevatten voor de oogchirurgie, gaande van mesjes en hechtdraden tot operatielakens en handschoenen. Het woord "Custom" verwijst naar het op maat maken van de pakketten. In het bedrijf zijn er ongeveer 1000 werknemers tewerkgesteld en dit aantal groeit nog steeds.

Function information

• 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.

Requirements

• 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

Offer

Interested?

Then contact :

mariam.sbihi@modisbelgium.be

Maraim Sbihi (Senior Talent Acquisition Expert)

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