Subject Matter Expert (SME) - Chemical API

Overview As the Subject Matter Expert (SME) - Chemical API for the Group you can be based from any of our Ireland, UK or Europe offices. Hybrid working in the role which will require travel to project meetings / workshops as required. Who we are PM Group is an employee owned, international project delivery firm with a team of 3,500+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners. Responsibilities To be a technology leader in nominated area(s) which includes : Being current in technical and subject knowledge Being aware of upcoming technology changes, developments, innovations Writing papers, presenting at industry conferences Being involved with industry bodies such as the ISPE, ICHEME (or equivalents) Promoting knowledge exchange within the company using appropriate forums, COPs, and teams To perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept and Basic Design phases). Typically this will include production and / or checking of early phase project deliverables appropriate to discipline speciality. This will include scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID’s and layout philosophies, early phase project reports To technically assist project teams as required. To undertake Peer Reviews of work performed by other companies. To perform in appropriate SMEs reviews of client sites. To engage with global network of SMEs and other staff and assist in the training and mentoring of the next generation of Subject Matter Experts in the company To participate and / or chair technical design reviews as appropriate. To support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements. To actively support and participate in the PM Group’s R&D Team (TechTeam) and associated development and innovation activities. To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials. To be 80% bookable. Travel to Project meetings / workshops as required Other special projects as assigned Specific Knowledge Areas to be covered by the Role include Deep knowledge in the processes involved in the development, scale-up and commercial production of Chemical APIs Aspects related to unit operations such as Reactions, Separation Operations, Crystallisation, Gas based reactions. Filtration, Centrifugation, Drying, Milling and blending Principles of facility layout such as : Layout adjacencies Stack-up Segregation approaches Aspects related to technologies such as : Batch, semi-continuous and continuous processing Solvent and reagent handling Materials handling Cleaning technologies Solid, liquid and gaseous waste handling and treatment Automation Utility generation and distribution Aspects related to project delivery such as : Basis of design Safety framework including relief systems, ATEX, and containment Simulation tools Tech Transfer Bid analysis Supplier interfacing Commissioning and Qualification Aspects related to facility operations such as : Operating philosophies GMP Regulatory framework Qualifications Bachelor’s degree; Masters preferred Appropriate level of experience around Chemical API facility design and operations A history of wider industry engagement with institutions such as the IChemE, ISPE (or equivalent) and an awareness of key industry technology initiatives and direction Excellent knowledge relating to area of speciality Direct experience working within capital projects and delivery related to process facility design and construction is essential. Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines Find out more about PM Group and our projects.