Chemical API Subject Matter Expert
2 weeks ago
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Chemical API Subject Matter Expert (SME), CorkClient: PM Group
Location: Cork, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 21f8417d7785
Job Views: 6
Posted: 18.06.2025
Expiry Date: 02.08.2025
Job Description:Overview: The Role
We have an exciting opportunity for a Chemical API SME to join our team. The role involves providing technical leadership on Chemical API as a Subject Matter Expert. The person employed can be located in any of the PM Group offices in Europe. We operate a hybrid work model, with travel to project meetings/workshops as required.
Who we are: PM Group is an employee-owned, international project delivery firm with over 3,500 employees. We are leaders in pharma, food, medtech, and mission-critical sectors, working with top organizations worldwide from our offices across Europe, Asia, and the US. We focus on sustainable growth centered around our people, clients, and trade partners.
Responsibilities include:
- Being a technology leader in nominated areas, staying current with technical knowledge and industry developments.
- Writing papers, presenting at industry conferences, and engaging with industry bodies like ISPE and ICHEME.
- Promoting knowledge exchange within the company.
- Performing as an SME during early project phases, including producing and reviewing project deliverables such as process flow diagrams, P&ID's, and layout philosophies.
- Assisting project teams technically and conducting peer reviews.
- Engaging with global SMEs, mentoring staff, and participating in technical design reviews.
- Supporting process risk assessments (HAZOP, LOPA, FMEA) to ensure safe operations and compliance.
- Participating in R&D activities and supporting business development efforts.
- Traveling as needed to project meetings and workshops.
Knowledge areas include:
- Deep expertise in development, scale-up, and production of Chemical APIs.
- Understanding unit operations like reactions, crystallization, filtration, and drying.
- Facility layout principles and technologies such as batch and continuous processing.
- Project delivery aspects including design basis, safety, simulation, tech transfer, and commissioning.
- Facility operations considerations, GMP, and regulatory frameworks.
Qualifications include:
- Bachelor's degree, Master's preferred.
- Over 15 years of experience in Chemical API facilities and operations.
- Active industry engagement and awareness of technological initiatives.
- Experience with capital projects, regulatory frameworks (FDA, EMA, ICH).
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