NPI Process Engineer – Pharma Process Development Transfer
Sterling Engineering Ltd - Ireland & Europe
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Job summary
Sterling Engineering Ltd - Ireland & Europe is seeking an experienced NPI / DP Process Engineer to support the introduction of new products into pharmaceutical manufacturing operations. The role focuses on process development, technical transfer, scale-up, risk assessment and ongoing technical support within a cGMP environment.
You will collaborate with cross-functional teams to ensure safe, efficient product introductions compliant with quality, regulatory and EHS requirements.
Qualifications
- A third-level degree in Engineering, Science or a related technical discipline.
- At least one year of experience in a similar role.
- Experience within the pharmaceutical or biopharmaceutical industry.
- Strong technical knowledge of DP fill-finish unit operations.
Responsibilities
- Conduct gap analyses and facility fit studies for NPI.
- Monitor process data to assess performance and identify improvements.
- Develop, optimise and implement DP processes for new products.
- Provide technical support to resolve process-related issues during manufacturing.
- Lead PFMEA and EHS assessments.
- Develop technology transfer plans and batch records.
- Collaborate with global teams on process development and product introduction.
- Lead investigations and change controls; support manufacturing improvements.
- Provide training to operations personnel involved in NPI processes.
- Ensure compliance with cGMP and EHS standards.
Skills
Education
Job description
Sterling Engineering Ltd - Ireland & Europe is seeking an experienced NPI / DP Process Engineer to support the introduction of new products into pharmaceutical manufacturing operations. The role focuses on process development, technical transfer, scale-up, risk assessment and ongoing technical support within a cGMP environment.
You will collaborate with cross-functional teams to ensure safe, efficient product introductions compliant with quality, regulatory and EHS requirements.
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