Ref No: DT17682
County Cork, Republic of Ireland
This position of API Engineer provides technical leadership and expertise in conjunction with the API contract manufacturer personnel in the reliable supply and commercialisation of medicines, with safety first and quality always, by:
• Developing and sustaining process knowledge in order to ensure the execution of the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CM's)
• Direct and indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy
• FUME assessment to ensure an understanding of risk presented to the operational control strategy
• Participation with internal or CM resources in equipment specification, procurement, and IQ/OQ/PQ
• Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact products
• Engage with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets.
Coach and Mentor Process Team Members-
• Utilise past experiences with unit operation control to provide insight and feedback to members of the CM Joint Process Team (JPT).
• Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT.
• Support and peer review root cause analysis around FUME and operational incidents.
• Peer review documentation of learning points, technical studies, and incident investigations.
Develop and Sustain Process Knowledge-
• Identify process knowledge gaps that impact equipment and process capability.
• Develop or support the capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, process modelling, and equipment design basis).
• Enable the development and maintenance of process knowledge, infrastructure such as key models, report history, lab models, and literature.
• Utilize optimisation resources and tools for process analysis and process improvement studies.
• Review and track key process engineering metrics.
Provide Process & Equipment Support-
• Identify systemic issues affecting production and reliable supply from CM's
• Lead or participate in root cause analysis and countermeasure development and implementation for major safety, quality, or throughput incident investigations. Perform reviews of incident documentation for technical accuracy.
• Review and approve documentation and engineering decisions.
Process Optimization & Continuous Improvement-
• Support development and technical analysis for on-going continuous improvement activities.
• Review and identify cost reduction opportunities, as well as process capacities and bottlenecks. Assist in prioritisation of opportunities with respect to overall business objectives.
• Work with the CM's to ensure the application of statistical thinking and methods to understand process variability and capability.
• Perform and promote optimisation of unit operation cycle time, loading, and yield performance.
• Engage with late phase development and Engineering Technical Center resources to stay contemporary with key engineering disciplines and developing portfolio platforms (e.g. continuous manufacturing operations).
Equipment Capability and Asset Management-
• Create an appropriate methodology to ensure visibility of the ongoing state of qualification of key FUME systems at the CM's.
• Review equipment and process system user requirements and qualification plans to ensure that the equipment and systems are appropriate for the intended purpose.
• Act as customer representative for review of Contact Manufacturer (CM) requests for capital projects targeted at both short and long term needs.
Oversight of HSE and PSM-
• Serve as the liaison for API EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at the relevant contract manufacturing sites.
• Leverage internal expertise in HSE and PSM to ensure appropriate risk reduction at CM's.
• Participate in HSE and PSM audits of contract manufacturing sites as applicable.
• Maintain key HSE and PSM metrics for review within API EM.
Adherence to Business, Quality, and Financial Systems-
• Understand and follow all applicable policies and procedures with respect to interactions and oversight of API contract manufacturing sites.
Interested applicants should have:
• At least 5 years' work experience in a manufacturing/process engineering related role
• Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations.
• Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
• Demonstrated ability to function in a team environment as a technical leader and as a member of teams.
• Demonstrated ability to manage and prioritise competing priorities and to appropriately communicate verbally and in writing to various audiences.
Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience.