Senior Process Engineer

2 weeks 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's commercial manufacturing facility in Hull. As a key member of our operations team, you will be responsible for optimizing and standardizing drug substance manufacture within the facility, as well as providing technical support for new product introductions and outsourced commercial drug substance projects.

Key Responsibilities
  • Provide technical support for existing drug substance manufacture, including monitoring/execution of validation batches, technical support for deviations, change controls, and technical audits.
  • Develop, review, and/or approve manufacturing batch records, ensuring suitable product manufacturing control plans are established and in-place to ensure safe and consistent manufacturing.
  • Assess long-term manufacturing capacity vs. long-term forecast to ensure sufficient capacity to support demand and develop/execute capacity expansion plans to address any projected deficiencies.
  • Lead in the design specification, FAT, SAT, and qualification of any 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, in collaboration with the CMC Lead, on technical transfer/process validation activities associated with site transfers of chemical processes.
  • Determine the manufacturing requirements of new chemical processes and assess the existing facilities capabilities to manufacture, preparing proposals to in-house such products under the umbrella of a cost benefit analysis.
  • Lead the development of engineering study and process validation protocols for in-house and/or 3rd party drug substance manufacturing.
  • Act as Indivior supply technical representative on all outsourced commercial drug substance projects, providing technical insights into risk and risk mitigation from the CMO.
  • Review of technical documents (e.g. design, validation, controls, etc.) from the CMO to ensure that they meet the expectations of Indivior.
  • Act as Indivior lead on critical manufacturing investigations, driving to true root cause and co-authoring investigation reports with appropriate scientific understanding.
  • Assist in the development and implementation of effective CAPAs to prevent the reoccurrence of product and process quality issues.
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 being able to take on an SME role in these activities.
  • Use of AutoCAD an advantage.
  • A recognised EHS qualification such as NEBOSH general is an advantage.
Benefits
  • 25 days holiday plus public holidays.
  • Flexible working; core working hours are 10am-3pm.
  • Up to 2 days working from home/week.
  • A flexible Friday programme.
  • Paid Volunteer Time Off.
  • 10% company pension.
  • EAP service including Legal, Health, Financial and Wellbeing support.
  • Optional Health Insurance with BUPA.
  • Company Death in Service and Payment Protection Insurance.
  • Access to platform for discounts on such as gym membership, shopping, holidays.

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