NPI Process Scientist

About the RoleWe are seeking an experienced NPI Process Scientist to join our clients Technical Operations team based in Ballytivnan. The successful candidate will play a key role in the development, introduction, scale-up and ongoing technical support of new products and processes within a highly regulated pharmaceutical/biologics manufacturing environment.

This is a technically focused role requiring strong problem-solving skills, attention to detail and the ability to work effectively across multidisciplinary and international teams. The successful candidate will operate with a high degree of autonomy while providing technical leadership and support to manufacturing operations.

Key Responsibilities:

• Assist in the development and optimisation of manufacturing processes for new products.
• Provide operational technical support for process-related issue resolution.
• Perform gap analyses, facility fit studies, process safety assessments and risk analyses for NPI activities.
• Monitor and analyse process data during manufacturing campaigns.
• Prepare, review and update specifications relating to NPI materials and consumables.
• Lead and/or support risk assessments, including PFMEA and EHS assessments.
• Develop NPI documentation, including transfer plans, protocols, procedures and manufacturing batch records.
• Work closely with global science, technical and quality teams on the development and introduction of future products.
• Lead and/or support product and process-related investigations and change plans.
• Support, supervise and train operations personnel in NPI processes.
• Provide technical input into process improvements and operational initiatives.
• Support successful introduction and implementation of new products onsite.
• Provide functional expertise and technical support to daily manufacturing operations.
• Support cross-functional teams and contribute to cost improvement and continuous improvement projects.
• Lead technical projects and sub-projects relating to commercial and NPI activities.
• Provide technical leadership to relevant functional areas and influence stakeholders on system and process improvements.
• Contribute to the successful delivery of site objectives, goals and technical initiatives.
• Maintain a strong focus on Right First Time, quality and compliance.
• Ensure activities are conducted in accordance with cGMP, regulatory requirements and company procedures.
• Work collaboratively with EHS teams to support safety-related activities and initiatives.
• Provide guidance and intermittent supervision to junior technical personnel, graduates, interns or other assigned staff as required.

Education & Experience: 

• Third-level degree in a relevant engineering, science or technical discipline.
• Minimum 3 years' experience in pharmaceutical process engineering, including relevant experience in
  • Batch processing
  • Technical transfers
  • Process scale-upcGMP manufacturing environments
• Pharmaceutical or biologics production
• Minimum 1 year's experience in a similar technical/NPI role.
• Minimum 1 year's experience within the pharmaceutical or biologics industry.
• Strong technical and operational knowledge of unit operations within a fill-finish manufacturing facility.
• Experience working within a highly regulated, quality-driven manufacturing environment.
• Demonstrated ability to troubleshoot complex process and operational issues.

Desirable: 

• Master's qualification in a relevant technical discipline.
• Experience with new product introductions into biologics manufacturing facilities.
• Experience leading or contributing to cross-functional technical projects.
• Experience with process risk assessment methodologies such as PFMEA.
• Experience supporting technical transfers and process validation activities.

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose