Validation Engineer / Business Development Manager, Process Engineering Specialists

  • Secteur d'activité: Biotechnologie / Chimie / Pharmaceutique
  • Type d'contrat: Temporaire
  • Taux d'occupation: Plein-temps (100%)
  • Catégorie d'emploi: Pharmaceutique / Biotechnologies / Chimie
  • Sub-catégorie d'emploi: Pharmaceutique
  • Date de publication: 22-04-2021
  • Délai de candidature: 22-05-2021
  • Référence: Validation Engineer / Business Development

Key Responsibilities:
 Support, counsel and coordinate commissioning activities of direct impact systems.
 Ensure commissioning activities are as per CMP.
 Review and approve commissioning protocols. 
 Establish and execute validation protocols including IQ, OQ, PQ and/or PV for multi-
disciplinary systems, including upstream biotech, downstream biotech, lab equipment, clean
utilities, clean rooms and CIP/SIP validation, process validation and CSV.
 Supervise /manage schedule for validation activities such as GMP status, equipment
qualification, audits and CAPAs. 
 Ensure proper qualification of systems with adherence to VMP and Quality.
 Conduct GMP and validation SOPs class room training for all staff from technicians to
Director level.
 Act as the main point of contact for project engineering change management and deviations,
including reviewing and approving project change controls and deviations.
 Complete weekly PCM status reports for senior management. 
 Ensure proper document management in KNEAT, and support the uploading of validation
documents in KNEAT. 
 Review hand over documents during project close out.
 Perform business development duties when needed, including presentation to clients,
outsourcing personnel, managing employees and managing company budget. 
 Perform other duties as assigned by manager. 

 


Key Requirements:
 Academic degree in Engineering.
 Minimum 12 – 15 years’ experience in a pharmaceutical GMP environment and knowledge in
GAMP5. 
 Experience in training people. 
 Experience in Business Development
 Extended knowledge in EU and US GMP regulations. 
 Knowledge in Good Documentation Practices in the pharmaceutical industry with hands on
experience in KNEAT software. 
 Ability to provide immediate solutions to engineering changes and challenges. 
 Experience in defining vendor scope and managing. 
 Excellent decision-making skills and can work under pressure.
 Preferred candidates shall have experience in validation for the following systems:
manufacturing equipment for both upstream and downstream biotech, CIP, SIP, clean rooms,
laboratory equipment, and process validation. 
 Languages: Should be fluent in written and spoken English, and have at least basic German

Contact
  • Email: fcassidy@pes-international.com
  • Nom du contact: Fintan Cassidy

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