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Senior Process Engineer

2 months ago

Hull, Kingston upon Hull, United Kingdom Indivior Full time
Job Summary

We are seeking a highly skilled Senior Process Engineer to join our team at Indivior. As a key member of our manufacturing team, you will be responsible for optimizing and standardizing drug substance manufacture within our facility.

Key Responsibilities
  • Provide technical support for existing drug substance manufacture, including monitoring and execution of validation batches, technical support for deviations, and technical audits.
  • Develop, review, and/or approve manufacturing batch records, ensuring suitable product manufacturing control plans are established and in-place.
  • Assess long-term manufacturing capacity vs. long-term forecast to ensure sufficient capacity to support demand and develop/execute capacity expansion plans.
  • Lead in the design specification, FAT, SAT, and qualification of new processing equipment and similar for equipment modifications, producing a full set of validation documents that achieve the standards expected in GMP from ICH Q7.
  • Partner with Engineering, Production, and Quality to execute improvement projects on site.
  • Act as Supply Lead on technical transfer/process validation activities associated with site transfers of chemical processes.
  • Lead the development of engineering study and process validation protocols for in-house and/or 3rd party drug substance manufacturing.
Requirements
  • 10+ years of API/chemical industry experience with a sound understanding of cGMP requirements.
  • Experience in process development, engineering, scale-up, and/or tech transfer.
  • Experience of process safety and hazard studies such as HAZOP and LOPA.
  • Use of AutoCAD an advantage.
  • A recognised EHS qualification such as NEBOSH general is an advantage.
Preferred Qualifications
  • Master's Degree in Science/Engineering with Experience.
  • Proven experience developing and problem-solving complex manufacturing processes within cross-functional teams.
  • Significant experience with API processes and related manufacturing equipment, including technical writing.
  • Demonstrated experience managing complex technical projects, covering both the technical and financial aspects.
Benefits

Indivior offers a competitive benefits package, including 25 days holiday plus public holidays, flexible working, and a range of other perks.