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.

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.