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Senior Process Engineer

4 months ago

Kingston upon Hull, United Kingdom Indivior Full time

POSITION SUMMARY:

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.

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

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 Continuous Improvement: Identify opportunities for improvement and justify via the CAPEX program in order to deliver the expected positive change to site performance

Project management

Along with the site leadership team develop the 5-year CAPEX plan and site strategy for investment 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.

New product introduction technical support

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

Outsourced drug substance technical support

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.

MINIMUM QUALIFICATIONS:

Education: BS Science /Engineering

MMINIMUM

Field of Study: Chemical Engineering or related discipline

Experience:

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

License/Certifications: N/A

Travel: Ability to accommodate up to ~20% travel (domestic and international) as required

COMPETENCIES/CONDUCT:  

In addition to the minimum qualifications, the employee will demonstrate:

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. Demonstrates team collaboration and professional behaviours to align with Indivior guiding principles and core values. Good interpersonal skills across multi-disciplinary teams and geographical locations. Proven ability to work under pressure, as a part of a team, without compromising quality and delivery. Ability to self-motivate & motivate others. Excellent communication and negotiation ability. Innovative with strong problem-solving ability.

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.

BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes

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 Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.