Ireland Job Openings
Amgen
Sr. Engineer Drug Process Development
Dún Laoghaire
September 9, 2024
Job Posting Title Sr Engineer - Drug Process Development
Career Category Process Development
Employee Subgroup TBC
Country (State/Region) Ireland
Location (City) Ireland - ADL
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.
Basic Qualifications
Career Category Process Development
Employee Subgroup TBC
Country (State/Region) Ireland
Location (City) Ireland - ADL
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 formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.
- Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
- Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
- Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
- Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
- Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions
- Conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
- Identifies and implements operational opportunities for current and new sterile operations.
Basic Qualifications
- Bachelors degree & 8 years of directly related experience OR
- Masters degree & 6 years of directly related experience
- Knowledge of aseptic manufacturing technologies and c GMPs
- Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
- 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 with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilisation would be an advantage.
- Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
- 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.
New Job Alerts
U.S. Bank National Association
Fund Accountant
Dublin
FULL TIME
September 22, 2024
View Job Description
Erin School of English
Sales and Student Advisor - South Africa & Botswana
Cork
PART TIME
September 22, 2024
View Job Description
Carlton Hotel Dublin Airport
Food and Beverage Assistant - Breakfast
Dublin
FULL TIME
September 22, 2024
View Job DescriptionLooking for similar job?
![Wills Bros Hiring Multiple Roles on Large Civil Engineering projects [ROI/UK]](/storage/logo/Wills_Bros.jpeg){kind=logo}
Wills Bros
Hiring Multiple Roles on Large Civil Engineering projects [ROI/UK]
Cork
August 23, 2024
View Job Description
Minerex Environmental
Junior Production Engineer
Dundrum
FULL TIME
August 23, 2024
View Job DescriptionNational Broadband Ireland
Junior NOC - NOC Engineer
Dublin
FULL TIME
August 27, 2024
View Job DescriptionSee What’s New: Amgen Job Opportunities
Amgen
English speaker General Assistant and Administration
Lisbon
September 14, 2024
View Job Description
New Job Alerts
U.S. Bank National Association
Fund Accountant
Dublin
FULL TIME
September 22, 2024
View Job Description
Erin School of English
Sales and Student Advisor - South Africa & Botswana
Cork
PART TIME
September 22, 2024
View Job Description
Carlton Hotel Dublin Airport
Food and Beverage Assistant - Breakfast
Dublin
FULL TIME
September 22, 2024
View Job Description