Senior Process Engineer
4 weeks ago
Senior Process Engineer - Pharmaceuticals page is loaded Senior Process Engineer - Pharmaceuticals
Apply locations Hull time type Full time posted on Posted 4 Days Ago job requisition id R2304 TITLE:
Senior Process Engineer - Pharmaceuticals Title: Senior Process Engineer- Pharmaceuticals
Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.
Indivior operates a drug substance manufacturing facility in Hull for the commercial manufacture of buprenorphine for use in the company’s marketed products. Indivior R&D uses a network of external vendors for development projects.
The purpose of the Senior Drug Substance Process Engineer role, which will be based in the commercial manufacturing facility in Hull, is to continuously optimise, standardise, and drive efficiencies for drug substance manufacture within the facility. This role will also be expected to provide manufacturing input and lead the technology transfers for new drug substances to be transferred into the facility. The role will also provide oversight of any commercial manufacturing carried out at external parties.
Technical support for existing drug substance manufacture.
Provide technical support for manufacturing and projects with strong understanding of relevant unit operations principles and functions (i.e. reaction, reflux, distillation, separation, crystallisation, and filtration, etc.), including the monitoring/execution of validation batches, technical support for deviations, change controls and technical audits
Develop, review, and/or approve manufacturing batch records, as necessary 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
Identify opportunities for improvement and justify via the CAPEX program in order to deliver the expected positive change to site performance
Project management
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
Assist in evaluating products and processes for any in-house manufacturing considerations
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
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.
Education: BS Science /Engineering
Field of Study: Chemical Engineering or related discipline
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
~ Use of AutoCAD an advantage
~ A recognised EHS qualification such as NEBOSH general is an advantage
Travel: Ability to accommodate up to ~20% travel (domestic and international) as required
A ‘See it, Own it, Make it Happen’ attitude and proven ability to evaluate and communicate risks.
Proven track record of delivering high quality work to tight deadlines.
Proven ability to work under pressure, as a part of a team, without compromising quality and delivery.
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.
25 days holiday plus public holidays
~ Flexible working; 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
~ Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
EOE/Minorities/Females/Vet/Disabled
Innovation. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient.
Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth. Care Enough to Coach
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