MSAT Scientist Mass Spectrometry

  • Location: Antwerp
  • Job #26795
MSAT Scientist Mass Spectrometry

Contracting – Antwerp

Main Responsibilities:

  • Develop, optimize, execute and/or transfer liquid-chromatography coupled to mass spectrometry (LC-MS) methods.
  • Act as expert for analytical HPLC and mass spectrometry.
  • Integrate characterization LC-MS data with process/product knowledge.
  • End-to-end method responsibility, starting with method development and optimization up to method execution, data reporting and documentation.
  • Experience with common analytical workflows (peptide mapping, release glycans) is a plus.
  • Identification of improvements for existing methods to introduce new technology, increase method robustness, and reduce release cycle time.
  • Investigational support for product and process, generation of scientific/technical study protocols and report. Impact assessment upon signification deviations in the analytical methods, production process and providing technical/scientific expertise.
  • Support analytical activities for product characterization, transfer and process improvements for products in late development, next-generation, or commercial phase.

Profile:

  • PhD or Master in Life Sciences with mass spectrometry experience – mandatory, or equivalent through relevant experience.
  • Prior hands-on experience with LC-MS is a must.
  • Experience with large molecule LC-MS data interpretation (at intact of peptide levels) is a plus.
  • Good fundamental understanding of chromatography methods and mass spectrometry and can rely on this knowledge to accelerate projects and support troubleshooting. Prior hands-on experience with LC-MS troubleshooting is highly desired.
  • At least 3 years of relevant experience in method development, validation, and investigation testing/support in an analytical function. This experience can be acquired as company or academic experience.
  • Good understanding of GMP and the manufacturing and testing of biologics.
  • Quality-oriented mindset.
  • Fluent in writing and speaking in English.
  • Flexible and willing to adapt to changing priorities and willing to learn at a rapid pace. You are willing to support small-scale studies, quality investigations and MSAT-driven projects both in the lab and as part of a cross-function team.
  • Excellent analytical problem-solving mindset, you are accurate and have an eye for details
  • Familiar with various statistical and data trending techniques.
  • Strong communicator, who can connect, go into discussion, and find compromises with people in other departments or sites.
  • English, fluent in writing and speaking
  • Mostly Dutch speaking environment/team

Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]

 

Qualification & Validation Engineer

  • Location: Antwerp
  • Remote: Remote
  • Job #26763

Qualification & Validation Engineer
Contracting – Antwerpen
Verantwoordelijkheden

  • Ontwikkelen, implementeren en uitvoeren van URS, SIA, DQ, IQ, OQ, PQ, RV en TM activiteiten voor kleinschalige apparatuur, inclusief de bijhorende software.
  • Opzetten en uitvoeren van validatiestudies voor cGMP-kritische processystemen om compliance met cGMP, gebruikers- en regelgevingsvereisten aan te tonen.
  • Uitvoeren van kwalificaties van systemen waar industriestandaarden bestaan maar interpretatie vereist is, conform cGMP, cGLP’s en Sanofi-procedures.
  • Zorgen dat de gekwalificeerde status van systemen steeds cGMP-conform blijft.
  • Ondersteunen van projecten in lijn met cGMP-regelgevingsnormen.
  • Op de hoogte blijven van nieuwe validatieregels en testpraktijken, en technische ondersteuning bieden m.b.t. FDA- en EU-vereisten.
  • Beheren van validatiedocumentatie van opmaak tot goedkeuring en implementatie.
  • Input leveren bij change assessments om te bepalen of wijzigingen impact hebben op de gekwalificeerde status en documentatie.

Profiel

  • Grondige kennis van cGMP-vereisten in een gereguleerde omgeving.
  • Begrip van relevante kwaliteits- en compliance-regelgeving.
  • Probleemoplossend en in staat om validatie-issues te troubleshooten.
  • Goede kennis van Quality Management Systems.
  • Ervaring: 2–4 jaar in een farmaceutische of healthcare productieomgeving, met specifieke ervaring in kwalificatie van kleinschalige apparatuur en bijhorende software.

Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]

Automation Engineer Expert

  • Location: Antwerp
  • Job #26456

Automation Project Engineer
Contracting – Heist-Op-Den-Berg

Key Responsibilities
·  Perform upgrades of outdated HMI systems to Siemens TIA Portal
·  Integrate Simatic Logon functionalities into systems
·  Convert existing WinCC configurations
·  Create and maintain validation lifecycle documents according to company and regulatory standards
·  Conduct testing of shopfloor systems
·  Assist with and execute validation protocols (IQ/OQ/PQ)
·  Develop Standard Operating Procedures (SOPs)
·  Provide support during operations/production startup of automation systems
Qualifications
·  Proven experience with Siemens TIA Portal and Step 7
·  Strong knowledge of GAMP5 and the System Validation Lifecycle
·  Solid understanding of the pharmaceutical industry and applicable standards (GxP, GDP)
·  Proficiency with Microsoft SQL
·  Fluent in Dutch and English, both verbal and written
·  Previous experience with project management in a pharmaceutical engineering environment

Our offer:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]