Aseptic Manufacturing Associate (Days or 165 shift role)
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Posted on:
8 days ago
Vacancies:
1 Vacancy
Job Summary
Career Category
ManufacturingJob Description
Aseptic Manufacturing Associate (Days or 16/5 shift role) L3 - Amgen Dun Laoghaire 2
Live
What you will do
Lets do this. Lets change the world. As part of Amgens Operations organization Manufacturing continuously strives to be a differentiated leader in the manufacturing of complex high-quality therapeutics for our patients.
The Manufacturing Associate (Level 3) is a senior operator role within the Amgen Dun Laoghaire (ADL2) Manufacturing team. This role will be working either days (Mon to Fri) or in a 16/5 shift environment. The role supports the aseptic Formulation and filling of biopharmaceuticals (vials/syringes) in compliance with Good Manufacturing Practices. The Manufacturing Associate will develop as an SME/lead Operator in a process area within ADL Manufacturing (Formulation Filling Lyophilisation Sterilisation) while ensuring all activities are completed to the highest standards of safety quality and performance. The successful candidate will build on a culture of diversity inclusion and belonging in fast-paced and evolving environment.
The successful candidate will be required to work in a day role or potentially 16/5 shift pattern.
Key Responsibilities:
- Lead and coordinate daily manufacturing activities to meet production targets and schedule in drug product formulation filling and supporting processes (component preparation and sterilisation sterile filtration SUS activities and filter integrity tests)
- Conduct pre- and post-task briefings to ensure safety and GMP compliance.
- Monitor process area performance manage issues and update performance boards.
- Operate and clean process equipment; execute validation protocols as needed.
- Support investigations and provide SME input on formulation filling component prep and aseptic processes.
- Responsible for creating SOPs training procedures GDEs other relevant documentation related for startup facility in ADL2.
- Responsible for supporting change control tasks in line with what is laid out in pre-Imp imp and post-imp stages.
- Develop proficiency in automation and MES systems (e.g. PAS/X EDMQ PI).
- Provide on-the-floor guidance coaching and feedback to team members.
- Act as a training lead and aseptic coach within your SME area.
- Foster a culture of trust diversity inclusion and continuous improvement.
- Adhere to cGMP and EHS standards; escalate deviations or safety concerns promptly.
- Participate in investigations and audits offering SME-level expertise.
- Support regulatory inspections and coach others on GMP and aseptic practices.
- Drive resolution of production issues and implement improvements.
- Lead problem-solving efforts (e.g. 5 Whys) and implement corrective actions.
- Champion lean practices and promote a culture of operational excellence.
Win
What we expect of you
The successful candidate for this role will bring the following education skills and experience
- Educated to pass Leaving Certificate standard or equivalent (third level qualification an advantage).
- 3 years experience in Syringe/Vial aseptic manufacturing operations or have related experience.
- Demonstrated capacity to learn quickly and adapt to new technology.
- Strong ability to lead challenge and positively influence in an interactive team environment.
- Knowledge of relevant regulations and regulatory requirements (GMP EH&S).
- Experience of implementation of lean initiatives in a highly regulated environment - Yellow Belt Qualification desirable.
- Familiarity with AI tools and curiosity to learn adapt and being a champion for use of Amgen allowed AI tools within teams
- Fluent English required.
Thrive
What you can expect of us
In addition to a competitive salary structure Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package including retirement and savings plan with generous company contributions group medical life and disability insurance. Discretionary annual bonus program. Exceptional learning development and career advancement opportunities empowering employees to grow and build long-term careers. At Amgen we are committed to nurturing talent and providing meaningful pathways for professional development.
Amgen is an equal opportunity employer.
.Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
