Sr. Engineer - Process & Equipment

Amgen SA; Dún Laoghaire; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) in Ireland is seeking a Senior Equipment Process Engineer to join the Drug Product Engineering team, supporting commercial aseptic drug product filling on site. You will own performance of critical manufacturing equipment and lead improvements across mechanical, electro-mechanical and automation systems.

Reporting to the Engineering Lead, you will use statistical analysis and CI methodologies to monitor trends, conduct root cause investigations, and drive maintenance

Qualifications

• Bachelor's degree in Engineering and experience in a regulated manufacturing environment.
• Experience using statistical tools and CI methodologies to improve equipment performance.
• Strong knowledge of mechanical, electro-mechanical and automation systems.

Responsibilities

• Owns equipment/systems in GMP manufacturing for Drug Product.
• Monitors day-to-day performance and analyzes trends to identify proactive improvements.
• Leads root-cause analysis, incident investigations and CAPA where needed.
• Drives change control, project management and lifecycle management of equipment.

Skills

Statistical analysis

Continuous improvement

Mechanical & automation

Project management

Education

Bachelor's degree in Engineering

Tools

Automation systems

Job description

Live

What you will do

Let’s do this. Let’s change the world.

Amgen Dun Laoghaire (ADL) is looking for a Senior Equipment Process Engineer to join our Drug Product Engineering team to support commercial aseptic Drug product filling on site. Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging.

This position will be responsible for performance drug product equipment on site. The Senior Equipment Process Engineer will report to the Engineering Lead and should have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering skills relating to mechanical, electro-mechanical and associated automation systems. The Senior Equipment Process Engineer will also have full overall responsibility for the reliability and life cycle of equipment.

Key Responsibilities

• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.


• Ownership of equipment/systems in a GMP regulated manufacturing setting that support the Drug Product manufacturing processes.


• Monitoring of day-to-day performance, including trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends.


• Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures.


• Lead technical root cause analysis, incident investigations and after action reviews when troubleshooting issues related to manufacturing equipment/systems.


• Lead solving complex problems, project management, equipment lifecycle management and operational excellence initiatives related to their systems / equipment.


• Develop and manage change control requests per established SOPs and processes.


• Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs.


• Communicating with key stake holders, in a responsive manner to ensure they are kept informed on all engineering activities.


• Working in a collaborative manner within cross functional work centre team, and contributes to investigations, Non-Conformance and CAPA closure.


• Responsible for a structured maintenance schedule which will align with the manufacturing schedule to minimise downtime. This includes routine PM’s and long term planning for vendor support on site and the procurement of major spare part assemblies in a timely manner to support larger overhauls.


• Responsible for the development and maintenance of spare parts lists for their system and appropriate levels of spares are maintained.

Win

What we expect of you

The successful candidate for this role will bring the following education, skills and experience.

Basic Qualifications

• Bachelor's degree in Engineering (Mechanical,Manufacturing, Mechatronics, Electrical or Chemical).


• Manufacturing experience in a regulated environment.


• Experience in the use of statistical analysis tool & continuous improvement methodologies.


• Problem solving and applied engineering skills relating to mechanical, electro-mechanical and associated automation systems.

Preferred Qualifications

• Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities.


• Direct experience supporting either Vial or Syringe Filling equipment.


• Solid leadership, technical writing, and communication/presentation skills.


• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.


• Experience in developing strategies for new product introduction and new technology deployment.


• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.


• Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate.


• Development and presentation of project plans to senior management.


• Day to day vendor management and contract negotiations with focus on equipment suppliers.


• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.


• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.


• Travel at various times may be required to support execution of projects.

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 opportunities employer