Single Use Process Scientist
Orion GroupIreland2 days ago
ContractScience
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Orion Group Life Sciences are currently recruiting a Single Use Process Scientist on behalf of our Multinational Pharmaceutical client based in Co. Sligo on an initial 12-month contract (with potential to extend).
Responsibilities
Requirements
Essential:
Technical Skills
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Responsibilities
- Perform gap analysis, facility fit studies, process safety, and risk assessments for NPI.
- Monitor and analyze process data during manufacturing.
- Assist in developing manufacturing processes for new products.
- Prepare and update specifications and NPI-related documents (Transfer Plans, Protocols, Procedures, Batch Records).
- Lead or assist risk assessments (e.g., PFMEA, EHS).
- Support investigations, change plans, and technical issue resolution.
- Supervise and train operations personnel on NPI processes.
- Collaborate with global science and quality teams on process development.
- Ensure compliance with EHS standards and cGMP regulations.
Requirements
Essential:
- Degree in engineering, science, or relevant technical discipline.
- Minimum 1 year in a similar role within Pharmaceutical or Biologics industries.
- Knowledge of unit operations within fill-finish or upstream facilities.
- Master’s degree in a relevant discipline.
- Experience in pharmaceutical process engineering, batch processing, technical transfers, scale-up, and NPI.
- Experience in ADC manufacturing and GMP process transfers.
- Experience in cleaning study design.
- Experience with upstream processing: UFDF, mixing, single-use systems, chromatography.
Technical Skills
- Expertise in Single-Use Technologies: bioreactors, mixing systems, tubing, connectors, and assembly design for new projects.
- GMP compliance and documentation experience.
- Hands-on equipment setup, operation, and troubleshooting of single-use systems.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Key Skills
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