Process Engineer – Longford
We are seeking an experienced, high caliber Process Engineer to support Drug Product manufacturing process improvements required for new product approvals and to meet legacy product regulatory commitments. A successful candidate will have drug product and/or drug/device combination process development and manufacturing experience. The candidate will be expected to apply process engineering knowledge in support of technology transfer to clinical and commercial manufacturing.
Qualifications and Education:
• BS/MS in Chemical/Biochemical Engineering, Mechanical Engineering, Biomedical Engineering, or Science
• Bachelor’s Degree + 3 years of Engineering or Operations experience
• Process/equipment development and optimization experience, late stage or commercial products experience with strong focus on manufacturing support.
• Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.
• Strong knowledge of Quality systems, drug product manufacturing and process validation. Work history with GMPs, regulatory filings and compliance issues for drug product and combination devices.
• Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment with enthusiasm and a proactive positive attitude.
For more details please please upload your CV in word format and contact Sylvester on 0949029944