Principal Manufacturing Systems Engineer - Amgen Dun Laoghaire Project Deli

at  Amgen

JOIN AMGEN’S MISSION OF SERVING PATIENTS

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

BASIC QUALIFICATIONS:

Doctorate degree in Engineering and 2 years of combined Information Systems and Manufacturing Process Automation experience
Or
Master’s degree in Engineering and 4 years of combined Information Systems and Manufacturing Process Automation experience
Or
Bachelor’s degree in Engineering and 6 years of combined Information Systems and Manufacturing Process Automation experience

PREFERRED QUALIFICATIONS:

• Engineering, Information Systems, Computer and/or Software GMP-regulated industry background with experience leading projects and resources.
• 8+ years of experience in manufacturing, including 5+ in Pharma/Biotech industry.
• 5+ years of combined experience with Automation/ Process Control Systems (PCS), Manufacturing Execution System (MES) and/or laboratory systems or IS platforms.
• 5+ years of experience with packaging and/or filling line systems.
• Strong communication, leadership, and teamwork skills.
• Innovative, technically minded, and problem-solving abilities.
• Effective verbal, and written communication, and facilitation skills in the English language.
• Proficient in two or more of the following software: Rockwell FactoryTalk, Rockwell PLCs, and/or OSIsoft PI Data Historian.
• Experience with Korber MES.
• Strong knowledge of GAMP software development lifecycle, ANSI/ISA-S88 & S95 industry standards and methodologies.
• Experience or knowledge of advanced technologies around Augmented Reality/Virtual Reality, Digital Control tower, Industrial Internet of Things (IIoT), and Instrument Data Acquisition (IDA).
• Familiarity with industry standards for software development life cycle methodologies and 21 CFR Part 11.
• Validation and change control methodology experience with understanding of cyber security and manufacturing network principles as applied to operations technologies.
• Experience in PCS/MES implementation, validation, and change control.

Let’s do this. Let’s change the world. In this vital role you will be part of Amgen’s manufacturing plant at Ireland. The facility continues to implement new technologies and industry 4.0 capabilities. On this role you may also support projects at other Amgen facilities.

• Lead the execution and successful delivery of varied portfolio of IS/Automation projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
• Accountable for end-to-end Technology projects delivery from the business case creation up to qualification and go live into manufacturing production. This includes scope definition, technical leadership, budget estimate and management, reporting, vendors engagement within other responsibilities.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by utilizing technical, project management, and business expertise.
• Performs cross system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solution. Manage multiple initiatives and priorities.
• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements.
• Effectively manage relationships with Peers, IS service owners, business partners, enterprise IS service partners, and vendors.
• Communicates with multiple levels within the organization, highlighting issues and proposing solutions.
• Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design.