**What will you do** The Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at Amgen Dun Laoghaire. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies. + Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in inspection. + Drives the establishment of visual inspection objectives, focusing on regulatory expectations and network alignment. + Supports make-a-batch exercises to determine facility fit and identify gaps in the Visual Inspection process. + Supports New Product Introduction with visual inspection method development and AVI characterization. + Supports calculation of defect limit updates for new products and re-evaluation of current products. + Provides expertise on defects identified during batch inspection and supports defect library updates. + Supports in the development of visual inspection team members. + Support in the development of new inspection lines – URS / Vendor Selection + Provides support for manufacturing and commercial activities. + Assists in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. + Assists in troubleshooting issues with drug product processing technologies and equipment. + Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learnt to deliver high-quality manufacturing processes. **Basic Qualifications** + Bachelors degree & 8 years of directly related experience OR + Masters degree & 6 years of directly related experience + Experience in a regulated and or vision related work environment Preferred **Preferred Qualifications** + 10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry. + Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations. + Experience in working with vision related systems and validation of inspection equipment. + Project management skills including the ability to manage multiple projects and evaluate project resource requirements. + Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. + Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.