Associate Director Process Engineering – APICOM (Active Pharmaceutical Ingredient Commercialisation)
Location Dublin
Competitive salary and benefits
The Associate Director will join a team utilising technical excellence to ensure the safe and timely introduction and manufacture of late stage clinical and commercial API from an API Commercialisation Facility (APICOM) being constructed in Dublin. This state‑of‑the‑art facility includes the latest manufacturing and digital technologies to support autonomous batch and continuous manufacturing. As part of a team of Manufacturing Technical Specialists and Process/Chemical Engineers, you will provide a deep understanding of batch and continuous API manufacturing and manufacturing innovation to ensure successful planning and accommodation of new processes, the transfer of process knowledge from development and deliver new technology projects within APICOM.
Initially the successful applicant will support the definition of the ways of working for APICOM as it transitions through detailed design, construction, commissioning, qualification and validation and into beneficial operation. They will support the development of clear understanding of the functionality of processing equipment and become digitally skilled to support the utilisation of leading‑edge data analysis, modelling and simulation and digital tools (e.g. electronic batch records). The responsibilities and requirements of the position once in beneficial operation are outlined below.
Key Responsibilities:
Carry out process engineering aspects of new active pharmaceutical ingredient project accommodation in a highly autonomous state‑of‑the‑art manufacturing facility, including scale up assessments, assessing chemical reaction hazards, pressure relief calculations, and reviewing the basis of safety.
Utilise engineering calculations to optimise equipment performance, troubleshoot issues, and enhance overall operational efficiency. Review and approve engineering calculations conducted by other team members, ensuring accuracy and compliance with standards.
Take ownership of critical business processes, ensuring alignment with industry standards and regulatory requirements. Represent the department as a Subject Matter Expert (SME) during internal and external audits, providing insights and guidance on process‑related matters.
Lead and/or take part in risk assessments as the process SME e.g. HAZOPs, HAZIDs, Process Risk Assessments.
Provide expert guidance and oversight on large‑scale capital projects to ensure adherence to AstraZeneca's standards and industry regulations. Collaborate with stakeholders to integrate Safety, Health, Environment (SHE) and Good Manufacturing Practice (GMP) standards into project plans and execution.
Apply technical knowledge to improvement projects and the evaluation of new technology/processes. Collaborate with specialist scientific and/or technology networks to bring new technologies into the facility.
Mentor and supervise junior colleagues and university students.
Essential Requirements:
A degree and/or PhD in Chemical Engineering
Chartered Chemical Engineer
Experience in pharmaceutical/fine chemical/food manufacturing
A well‑developed understanding of unit operations such as mixing, distillation, liquid‑liquid extraction, isolation and drying and their dependency on scale and equipment
Good collaborative skills to enable effective working with different skillsets
Good understanding of the requirements, principles and application of process safety and Good Manufacturing Practice (GMP)
Strong communication and influencing skills
Preferred Requirements:
Experience of chemical process development scale up and/or technical transfer
Good understanding of the requirements, principles and application of Good Manufacturing Practice (GMP)
Experience of working across skillsets (e.g. with chemists, analysts and physical properties experts)
Ability to use modelling software (e.g. Aspen, DynoChem, gPROMS, Computational Fluid Dynamics) to support process understanding
Experience in continuous processing and advanced process control
Experience in leading technical projects or acting as a lead process engineer on a project
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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