Sr. Engineer Process Development
- Dún Laoghaire, Co Dublin
- Permanent
- Full-time
- Providing technical expertise in sterile drug product unit operations such as formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
- Leading, coaching and developing a team of process development SMEs, fostering technical development and supporting team growth.
- Leading or contributing significantly to product and process investigations, including root cause analysis and product impact assessments.
- Acting as a subject matter expert during change control, assessing the impact of proposed changes on the product and process performance.
- Supporting new product introductions (NPI), including recipe and protocol development, batch execution support and troubleshooting.
- Driving continuous improvement initiatives to enhance process capability, reduce variability and improve productivity.
- Analysing manufacturing data trends to identify opportunities for improvement and prevent potential issues.
- Reviewing and approving GMP documentation such as SOPs, electronic batch records, and product technical documentation.
- Collaborating with cross-functional and global teams to ensure alignment and execution of strategies with potential for advancement in network roles such as Drug Product Team Lead etc.
- Bachelor’s or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 4 years of directly related experience.
- Demonstrated leadership skills with the ability to build teams, and operate across functional boundaries, both internal and external
- Typically 6+ years of drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation.
- Strong leadership capabilities, with experience guiding teams or technical initiatives and supporting team development.
- Demonstrated experience in parenteral drug product manufacturing and delivery of cross functional, complex technical projects.
- Strong problem-solving technical skills related to parenteral drug product manufacturing.
- Thorough knowledge of GMP biotechnology manufacturing, with a significant understanding and knowledge of cGMPs. Experience with regulatory agency audits is beneficial.