Senior Process Engineer - Hull, East Yorkshire, United Kingdom - Indivior PLC

Description

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Senior Process Engineer - Pharmaceuticals

TITLE:

Title: Senior Process Engineer- Pharmaceuticals

Reports To: FCP Site Director

Location: Hull, UK

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 name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. 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.

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.

GUIDING PRINCIPLES:

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.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled

About Us

Passion. Innovation. Achievement. All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient.

The Indivior leadership team has built a global organization of individuals connected by a thriving culture. 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. It is our set of "Guiding Principles" that we believe have nurtured our culture and successfully guided our decision making.

Focus on Patient Needs to Drive Decisions Believe that People's Actions are Well Intended Seek the Wisdom of the Team Care Enough to Coach See it, Own it, Make it Happen Demonstrate Honesty and Integrity at All Times

For those who are seeking a unique growth opportunity with a company that takes entrepreneurial approaches to creating value, we invite you to join us in our purpose to continue to pioneer life-transforming treatments for patients around the world. We look forward to hearing from you.