Sr. Engineer Drug Process Development Inspection

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.