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Senior Commercialization Engineer

msd · IRL - Tipperary - Ballydine

New
Hybrid Senior 🇬🇧 English
Chemical Engineering API manufacturing Process Development GMP Regulatory compliance Process validation Process monitoring Process optimization Deviation investigation Root cause analysis Change control processes Engineering standards Environmental health and safety

Job description

About the role

An amazing opportunity has arisen for a Senior Commercialisation Engineer to support internal and external manufacturing operations, ensure continuous improvement and drive innovation in API production.

Key responsibilities

  • Guide new product introductions and technical transfers, including new technologies, across the site.
  • Collaborate with multi‑functional, global R&D teams to meet product launch milestones.
  • Evaluate raw materials, develop process fits, and optimise chemical API processes.
  • Participate in campaign preparation, safety and environmental reviews, and batch sheet assessments.
  • Ensure regulatory, validation and GMP compliance throughout process monitoring and time‑cycle studies.
  • Lead deviation investigations, root‑cause analysis and develop filing strategies.

Required profile

  • Dedicated, approachable and reliable professional with high personal integrity.
  • Self‑motivated problem‑solver able to lead improvement initiatives.
  • Proven ability to work effectively within diverse, cross‑functional teams.

Required skills

  • Chemical Engineering qualification.
  • Minimum 5 years experience in pharmaceutical API manufacturing or process development.
  • Expertise in GMP, regulatory compliance and process validation.
  • Strong knowledge of process monitoring, optimisation and scale‑up.
  • Experience with deviation investigation, root‑cause analysis and change‑control processes.
  • Familiarity with biopharmaceutical industry standards and engineering standards.

Questions fréquentes

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Source : ats:workday

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Published 1 hour ago

Expires 1 month from now

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msd

IRL - Tipperary - Ballydine