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MS&T Director – Sterile Technical SME (Visual Inspection)

MS&T Director – Sterile Technical SME (Visual Inspection)
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Pavia
À distance
EUR 70 000 - 110 000
Poste urgent
Il y a 5 jours
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MS&T Director – Sterile Technical SME (Visual Inspection)

Faites partie des premiers candidats.
Thermo Fisher Scientific Inc.
Pavia
À distance
EUR 70 000 - 110 000
Faites partie des premiers candidats.
Il y a 5 jours
Description du poste

Position : MS&T Director – Sterile Technical SME (Visual Inspection)

Reports To : DPD Division MSAT Head

Location : Remote (EU / US)

Preferred Locations :

  • UK : Swindon
  • France : Bourgoin

These locations are key sites for our operations

POSITION SUMMARY

Work for Thermo Fisher Scientific as a Global Technical SME in Visual Inspection. Contribute to improve visual inspection process globally.

Key responsibilities

Manufacturing Support :

  • Offer expertise in visual inspection for pharmaceutical processes, assist in strategy creation, set global standards, and ensure consistency in DPD sterile sites
  • Offer significant expertise on common VI technologies / equipment (Manual / Semi-automatic / Automatic) and Leak Detection systems
  • Knowledgeable about AI application to AVI (e.g., recipes creation / optimization, support to validation)
  • Perform process characterization of related pharmaceutical processes to increase robustness and sustainability
  • Support sites in troubleshooting / root cause investigation by providing second-level specialist expertise and harmonizing related technical processes across units
  • Review sterile site aseptic practices and set a plan for improvements and adaptations
  • Work closely with sterile manufacturing site teams to efficiently implement new technologies and ensure timely product launches
  • Monitor GMP, EU, and FDA regulatory changes and requirements, review industry-specific journals and periodicals
  • Support projects requiring expertise in aseptic manufacturing and lyophilization technology
  • Provide technical support in aseptic manufacturing, validation, new technologies, and sterilization; facilitate IQ, OQ, and PQ equipment and process qualifications upon request
  • Identify and drive opportunities for improvement, suggesting ways to improve process effectiveness, product quality, and operating efficiency
  • Support the development of Training Curriculum for Site SMEs and assure alignment across sites
  • Provide training and education on related technologies to site employees

Stewardship for Aseptic Network & New Product Launch :

  • Serve as the Network SME, collaborating with local and global MSAT networks to establish technical standards for current and upcoming technologies and equipment.
  • Assure internal and external benchmarking to stimulate knowledge, growing associates' know-how and spreading it across the organization
  • Author and implement GOPs for assigned technologies

Qualifications and requirements

  • MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field
  • Significant career experience in GMP manufacturing relevant to the specialist area of expertise
  • Validated process understanding (Pharma, GMP, Regulatory aspects)
  • Up to 30-40% travel, as needed
  • Confident communicator both verbally and in writing
  • Able to influence others and build cross-functional teams while setting clear business objectives
  • Proven leadership and technical experience

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* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.

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