Website Asset Recruitment
Process Engineer (TT/NPI)
The Process Engineer (Technology Transfer / New Product Introduction) will provide key technical leadership and support in the areas of new product introduction, development batch planning/execution and product launch activity technical support. They will ensure that a TT/NPI plan is developed, and all required documentation is generated to support same. They will work cross functionally with Operations, Quality, Engineering etc. to successfully qualify and validate the new product.
The Process Engineer will also support manufacturing process troubleshooting and continuous improvement initiatives as required.
The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.
• Works with manufacturing and quality colleagues as part of a Technical Services team whose shared goal is to realise the safety, quality, delivery, and cost objectives of the site.
• Leads technology transfer and other development projects from a scoping, technical assessment, and technical management perspective. This includes developing procedures, protocols, plans and risk assessments.
• Supports international regulatory filings through the authoring or review of relevant submission documents as required.
• Works with global Company and Partner colleagues to meet the launch and supply objectives of the organisation.
• Provides regular updates to management on technology transfer project plans, status and risks/mitigations.
• Responsible for developing and rolling out new systems on site such as Continuous Process Validation (eg CPP trending)
• Is part of a process SME team for products, supporting or leading product related deviations, change controls and CAPAs where required.
• Supports manufacturing by leading/supporting deviation investigations and is familiar with structured problem solving and root cause analysis.
• Supports validation activity in process manufacturing areas.
• Provides training and mentoring to build technical capabilities among teams.
• Supports capital projects throughout equipment lifecycle.
• Bachelors Degree in Engineering, Pharmaceutical Sciences, or related Science discipline.
• At least 5 years relevant experience in a pharmaceutical manufacturing environment, with at least 3 years’ experience in a comparable process engineering/technical services role.
• Experience leading technology transfer projects and supporting product launches would be an advantage
• Specific knowledge of sterile pharmaceutical manufacturing processes and technologies. Ideally, aseptic filling operations.
• Broad knowledge of NPI with ability to lead or support any NPI into the site.
• Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
• Strong analytical skills, documentation skills and research skills – strong attention to detail in generation of technology transfer and other documents.
• Strong understanding of pharmaceutical industry regulatory requirements.
• Experience managing key internal and external stakeholders.