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Senior Process Engineer

2 months ago

Hull, Kingston upon Hull, United Kingdom Indivior Full time
Job Title: Senior Process Engineer

Indivior is seeking a highly skilled Senior Process Engineer to join our team in Hull, UK. 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, 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.
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, with the ability 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.
Preferred Qualifications:
  • Master's Degree in Science/Engineering with Experience.
  • Proven experience developing and problem-solving complex manufacturing processes within cross-functional teams (CMC/R&D, QA, CMOs).
  • Significant experience with API processes and related manufacturing equipment, including technical writing (batch records, SOPs, CAPAs, and investigations).
  • Demonstrated experience managing complex technical projects, covering both the technical and financial aspects.
  • Experience ensuring process hazard data such as reaction calorimetry, energy of reaction, thermal stability, and minimum energy of ignition, is available to tech transfer team for product siting.
  • Experience with 3rd party CMOs and controlled substances.
What We Offer:
  • 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.