Aseptic Manufacturing Associate (Shift)

Amgen Inc; Ireland; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading biopharmaceutical company based in Dun Laoghaire, Ireland, is seeking an Aseptic Manufacturing Associate (Shift) to oversee aseptic manufacturing processes. This senior operator role involves leading daily production activities, ensuring compliance with GMP standards, and fostering a culture of diversity and inclusion. Candidates should have a minimum of 3 years' experience in aseptic manufacturing, strong leadership skills, and familiarity with automation systems. The position offers comprehensive benefits and competitive salary.

Benefits

Competitive salary

Group medical insurance

Retirement and savings plan with company contributions

Discretionary annual bonus program

Learning and career advancement opportunities

Qualifications

• 3+ years’ experience in Syringe/Vial aseptic manufacturing operations.
• Demonstrated ability to learn quickly and adapt to new technologies.
• Knowledge of relevant regulations and regulatory requirements (GMP, EH&S).

Responsibilities

• Lead manufacturing activities in drug product formulation and filling.
• Conduct safety and GMP compliance briefings.
• Monitor process performance and manage issues.

Skills

Experience in Syringe/Vial aseptic manufacturing operations

Strong team leadership

Knowledge of GMP regulations

Familiarity with automation and MES systems

Implementing lean initiatives

Education

Leaving Certificate or equivalent

Tools

PAS/X

EDMQ

PI

Job description

Aseptic Manufacturing Associate (Shift) page is loaded## Aseptic Manufacturing Associate (Shift)remote type: On Sitelocations: Ireland - Dun Laoghairetime type: Full timeposted on: Posted Todayjob requisition id: R-232376## **Career Category**Manufacturing## ## **Job Description****Aseptic Manufacturing Associate – L3 - Amgen Dun Laoghaire 2****Live****What you will do**Let’s do this. Let’s change the world. As part of Amgen’s 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 (ADL) Manufacturing team, working in a 24/7 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 a 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 SOP’s, training procedures, GDE’s, 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.*.