NPI Process Scientist

Sterling Engineering; Sligo; On-site; EUR 70,000 - 95,000; Full time

Job summary

Sterling Engineering is seeking an experienced NPI Process Scientist to join our Technical Operations team in Ballytivnan. The role focuses on development, introduction, scale-up and ongoing technical support of new products in a regulated pharmaceutical/biologics environment.

The successful candidate will lead technical projects, support operations, and work with cross-functional teams to ensure Right First Time, quality, and compliance.

Qualifications

• Third-level degree in a relevant engineering, science or technical discipline.
• Minimum 3 years' experience in pharmaceutical process engineering.
• Experience with batch processing and process scale-up.
• Strong knowledge of cGMP manufacturing environments.
• Experience supporting tech transfers and process validation activities.

Responsibilities

• Assist in development and optimisation of manufacturing processes for new products.
• Provide operational technical support for process-related issue resolution.
• Lead and support risk assessments (PFMEA and EHS) for NPI activities.
• Develop NPI documentation including transfer plans, protocols and batch records.
• Collaborate with global teams on development and introduction of future products.

Skills

Process engineering

Batch processing

cGMP knowledge

Problem solving

Education

Bachelors or higher in engineering/science

Job description

Job Description

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 By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose Benefits: null TPBN1_IJ