Senior Process Engineer - Pharmaceuticals
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.
POSITION SUMMARY:
The purpose of the Senior Drug Substance Process Engineer role 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.
ESSENTIAL FUNCTIONS:
The responsibilities of this job include, but are not limited to, the following:
1. Technical support for existing drug substance manufacture, including the monitoring/execution of validation batches and technical support for deviations.
2. Develop, review, and/or approve manufacturing batch records, ensuring suitable product manufacturing control plans are established.
3. Assess long-term manufacturing capacity vs. long-term forecast to ensure sufficient capacity to support demand.
4. Identify opportunities for improvement and justify via the CAPEX program.
Project management:
1. Develop the 5-year CAPEX plan and site strategy for investment.
2. Lead in the design specification, FAT, SAT, and qualification of any new processing equipment.
3. Partner with Engineering, Production and Quality to execute improvement projects on site.
New product introduction technical support:
1. Act as Supply Lead on technical transfer/process validation activities.
2. Determine the manufacturing requirements of new chemical processes.
3. Lead the development of engineering study and process validation protocols.
Outsourced drug substance technical support:
1. Act as Indivior supply technical representative on all outsourced commercial drug substance projects.
2. Review technical documents from the CMO to ensure they meet Indivior's expectations.
3. Assist in the development and implementation of effective CAPAs.
MINIMUM QUALIFICATIONS:
Education: BS Science / Engineering
Field of Study: Chemical Engineering or related discipline
Experience:
1. 10+ years of API/chemical industry experience with a sound understanding of cGMP requirements.
2. Experience in process development, engineering, scale-up, and/or tech transfer.
3. Experience of process safety and hazard studies.
Travel: Ability to accommodate up to ~20% travel (domestic and international) as required.
COMPETENCIES/CONDUCT:
1. A ‘See it, Own it, Make it Happen’ attitude.
2. Proven track record of delivering high quality work to tight deadlines.
3. Good interpersonal skills across multi-disciplinary teams.
PREFERRED QUALIFICATIONS:
1. Master's Degree in Science/Engineering.
2. Proven experience developing and problem-solving complex manufacturing processes.
BENEFITS:
1. 25 days holiday plus public holidays.
2. Flexible working; core working hours are 10am-3pm.
3. 10% company pension.
EQUAL EMPLOYMENT OPPORTUNITY:
EOE/Minorities/Females/Vet/Disabled
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