: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 arePM 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. :
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
:
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 and ourWhy PM Group?As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Please visit our website to read more in our Corporate Responsibility & Health and Safety Report 2020.Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
