Overview
Who we are
PM Group is an employee-owned, international project delivery firm with a team of 3,700+ 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.
We are excited to announce an opportunity for an experienced Process Engineer to join PM Group, working with a leading client in Mayo. The ideal candidate will bring strong expertise in Aseptic processing, Biopharmaceutical Drug Product and Equipment Optimization, with Drug Substance knowledge being an advantage.
Responsibilities
Main responsibilities will include:
1. Reviews and approves system lifecycle documentation (FS, SDS, IO lists, etc.) and ensures they meet requirements.
2. Integrate experiences and approaches from multiple projects/disciplines to develop the best solution for the business. Benchmark with other sites on projects and initiatives to ensure alignment across the organization and ensure best practices and designs are implemented.
3. Source for plant consistency across the network, share problem-solving activities, and maintain updated technical learning history.
4. Complete End to End assessments.
5. Complete and Support Design Operable studies.
6. Support QA Risk assessments.
7. Complete Process flow diagrams.
8. Support knowledge transfer of processes to site Technical/Operation SME.
9. Support, when needed, the commercial manufacturing of third-party products and serve as technical contact.
10. Generates FAT, SAT, and commissioning protocols for assigned equipment and ensures protocols meet specifications.
Qualifications
Experience & Skills:
1. Engineering 3rd level qualification (Chemical, Process Engineering, or equivalent).
2. Show proven expertise in the provision of personnel to meet the requirements.
3. 6+ years of significant operational and/or engineering experience ideally gained in an Aseptic Manufacturing environment.
4. Strong technical knowledge of equipment – Tanks, Aseptic Fill lines & Lyos.
5. Strong Technical Knowledge of SUS systems.
6. Project and/or operations experience within a process or biopharmaceutical cGMP regulated environment.
7. Experience of bioprocessing equipment specification, design, commissioning, and operation.
As an employee-owned company, we are inclusive, committed, and driven. Corporate Responsibility and Sustainability are at the heart of our new 2025 business strategy.
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.
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