Snr Associate Manufacturing
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Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Career Category
ManufacturingJob Description
Manufacturing Senior Associate
Amgen Dun Laoghaire
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 manufacture of complex high-quality therapeutics for our patients.
The Senior Associate reports to the Manager Manufacturing. The ideal candidate will provide strong leadership to the Manufacturing teams on a 24/7 shift pattern in a sterile Drug Product facility in fast paced and evolving environment. They will have strong GMP and quality system knowledge and the ability coach/mentor a team on the quality system requirements as well as maintaining a strong culture of safety within their shift team and in the manufacturing area in general. The candidate will have excellent troubleshooting skills using standard industry problem solving techniques.
The successful candidates will be required to work a shift pattern.
Key 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.
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
A third level qualification in a relevantsubject 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.
Demonstrated understanding and use of right first-time techniques and lean manufacturing concepts.
Results-oriented.
Excellent organizational communicational and team development skills.
Strong understanding of the quality system requirements and regulations for working in an aseptic drug product facility.
Excellent communication skills.
Team leadership experience (preferred).
Excellent computer skills - knowledge of Electronic Batch Records Quality Management Systems and Performance management Systems.
Fluent English .
Thrive
What you can expect of us
In addition to the base salary Amgen offers a Total Rewards Plan designed to support your health financial wellbeing work/life balance and long-term career growth. Comprehensive employee benefits package including health and welfare plans for staff and eligible dependents 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
