Senior Engineer - Process & Equipment

Amgen; Dublin; On-site; EUR 70,000 - 95,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) is seeking a Senior Equipment Process Engineer to join the Drug Product Engineering team. You will be responsible for performance and lifecycle of equipment in a GMP manufacturing setting, including analytics, maintenance planning and change control.

The role reports to the Engineering Lead and requires expertise in mechanical, electro-mechanical and automation systems. We expect strong problem solving, collaboration with cross-functional teams and experience with

Qualifications

• Bachelor's degree in Engineering in a relevant field.
• Manufacturing experience in a regulated environment.
• Experience using statistical analysis tools and continuous improvement methodologies.
• Problem solving and applied engineering skills relating to mechanical, electro-mechanical and automation systems.

Responsibilities

• Own and monitor equipment/systems in GMP manufacturing.
• Lead system improvements, write specifications and SOPs.
• Perform root cause analysis, investigations and CAPA closure.
• Manage change control requests and new product/technology introductions.
• Coordinate with stakeholders and cross-functional teams to minimise downtime and plan maintenance.

Skills

Statistical analysis tools

Problem solving

Automation systems

Education

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

Tools

Automation tools

Job description

Career Category Engineering 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.

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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range 70,408.90 EUR - 95,259.10 EUR

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.