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.
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