Source description
About the role
Job Title: MSAT Engineer (Process Chemist)
Duration: 12 Months
Location: Cork, IRL
Responsibilities
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Process Optimization and Monitoring:
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Perform laboratory scale experiments to support manufacturing non-conformances and lead continuous improvement projects (CIPs) including impurity purging capability, yield improvement, cycle time reduction and particle size distribution (PSD) optimisation.
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Serve as the Subject Matter Expert (SME) for Process Analytical Technology (PAT) initiatives, including plant-based MID-IR and Lasentec (FBRM) technology for monitoring critical parameters.
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Mobilize cross-functional teams to deploy live Multivariate Analysis (MVA) models, facilitating continuous process improvement.
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Investigations and Innovation:
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Act as the Technical Process SME for Manufacturing Operations, providing expertise on investigations related to impurity deviations, low yields, emulsions, and PSD issues, while ensuring compliance with cGMP standards.
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Collaborate with internal and external stakeholders, including Regulatory Owners and Technical Owners, to support investigations, change controls, and CAPA development.
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Lead complex investigations with cross-functional teams, applying analytical and problem-solving skills to determine root causes, assess impacts, and implement process improvements.
Requirements
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PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
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Minimum of 3 years of experience in a similar role within the pharmaceutical industry or equivalent.
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Experience in PAT techniques, MVA, and process optimization methodologies preferred.
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Strong understanding of cGMP regulations and experience in supporting investigations and regulatory audits.
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Excellent communication and collaboration skills, with the ability to lead cross-functional teams and drive process improvement initiatives.
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Demonstrated leadership abilities, including experience in project management and team coordination. Reference: 24-03005
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