CP Process Engineer

3 weeks ago

Sligo, Ireland Sterling Engineering Full time

DP Process Engineer Department Overview We are seeking an experienced DP Process Engineer to support the introduction, tech transfer, and manufacturing readiness of new drug product (DP) processes within a biologics fillfinish environment. The successful candidate will play a key role in process development, facility fit assessments, risk evaluations, documentation creation, and technical support during GMP manufacturing. This position requires strong technical capability, excellent problem-solving skills, and the ability to collaborate effectively across Operations, Quality, and global scientific teams. Key Responsibilities Process Development & Technical Transfer Perform gap analyses, facility fit studies, process safety reviews, and risk assessments for New Product Introductions (NPI). Assist in developing and optimizing manufacturing processes for new biologic products. Support technical transfer activities including process assessments, cleaning assessments, and documentation readiness. Monitor and analyze process performance data during manufacturing campaigns. Technical Support & Troubleshooting Provide operational technical support for process deviations and issue resolution. Lead or assist investigations, root-cause analysis, and implementation of process improvements. Prepare, maintain, and update specifications for NPI materials, components, and consumables. Documentation & Risk Management Lead or support PFMEA, EHS, and other process risk assessments. Develop NPI-related documentation such as transfer plans, protocols, procedures, and manufacturing batch records. Collaboration & Training Work closely with cross-functional and global teams throughout process development and NPI execution. Support, train, and supervise operations personnel on new processes and procedures. Ensure adherence to all EHS&E standards, policies, and procedures. Essential Requirements Bachelors degree in Engineering, Science, or a related technical discipline. Experience with biologics DP fillfinish processes. Experience with lyophilized (LYO) products. Experience supporting technical transfer activities (e.g., gap assessments, cleaning assessments). Familiarity with single-use system design for DP operations. Desired Requirements Masters degree in a relevant technical discipline (preferred). Minimum 3 years experience in pharmaceutical or biologics process engineering, including scale-up and tech transfer in a cGMP environment. Experience with new product introductions in biologics manufacturing. Additional Skills Minimum 1 year in a similar role within the pharmaceutical or biopharmaceutical industry. Strong technical and operational understanding of fillfinish unit operations. Excellent analytical, communication, and cross-functional collaboration skills. 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.

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