Senior Manufacturing Associate - Sterile Parenteral Shift

Amgen Foundation, Inc.; Dún Laoghaire; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Competitive salary and benefits

Total Rewards Plans

Job summary

Amgen Ireland invites applications for a Senior Associate Manufacturing to join our fast-paced site in the Dublin area. This role reports to the Shift Manager and focuses on the manufacture of sterile parenteral drugs, with emphasis on GMP compliance, training, and continuous improvement.

The successful candidate will lead a shift of Process Technicians, coordinate with cross-functional teams, maintain production schedules, and support regulatory audits.

Qualifications

• Educated to pass Leaving Certificate standard or equivalent.
• A third level qualification in a relevant subject area would be an advantage.
• Applicants should have relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment. Aseptic experience preferred.
• Significant experience in a GMP/other regulated environment.
• Demonstrated knowledge of GMP principles.
• Demonstrated aseptic knowledge in GMP areas.
• Drug product manufacturing experience.
• Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels.
• Demonstrated ability to deliver to team, site and personal objectives.
• Fluent English required.

Responsibilities

• Support the Manufacturing Manager in leading a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and regulatory standards.
• Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule.
• Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans.
• Maintain an accurate, up-to-date manufacturing schedule reflecting current status of production and plan critical path activities.
• Foster a good safety culture in our team and act as a safety role model.
• Oversee completion and review of documentation (batch records, EBRs) using relevant software systems and Standard Operating Procedures (SOPs).
• Proactively identify training needs and facilitate completion of training to meet the area resource and cross training models.
• Assist, plan and implement continuous improvement initiatives using lean principles.
• Proactively identify and resolve process issues (including escalation and follow up) to minimize production disruptions.
• Support and assist with corporate, FDA, HPRA and other regulatory bodies during company audits.
• Lead on the 24/7 shift team in the absence of the Manufacturing Manager.

Skills

Fluent English

Team leadership

Excellent communication

Results-oriented

Strong organizational skills

Safety culture advocate

Education

Leaving Certificate or equivalent

Third-level qualification in relevant subject

Tools

Electronic Batch Records

Quality Management Systems

Performance management Systems

Job description

Amgen Ireland invites applications for a Senior Associate Manufacturing to join our fast-paced site in the Dublin area. This role reports to the Shift Manager and focuses on the manufacture of sterile parenteral drugs, with emphasis on GMP compliance, training, and continuous improvement.

The successful candidate will lead a shift of Process Technicians, coordinate with cross-functional teams, maintain production schedules, and support regulatory audits.