Prinicpal Manufacturing Systems Engineer

at  Amgen

PRINCIPAL MANUFACTURING SYSTEMS ENGINEER

Amgen is the world’s leading biopharmaceutical company with a versatile portfolio of products. Our science-based approach has led to the discovery of novel therapies in the areas of cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Our patient-centered culture fuels our commitment to delight their experience with innovative medicine delivery systems. At Amgen, new ideas are not just welcomed, but celebrated. You will be joining a team of over 20,000 inspirational colleagues eager to have a positive impact with one mission: to serve every patient every time.
Are you looking for a meaningful new opportunity applying latest available and emerging technologies to systems that enable the successful development, design, manufacturing, distribution and commercialization of Amgen products? We are looking for a creative, innovative, highly motivated and strategic Information Systems professional to lead the design and deployment of Manufacturing Information & Technology Systems in the areas of filling process automation, MES, data historian, advanced analytics and Artificial Intelligence (AI) for our fill, finish and packaging manufacturing facility in Dun Laoghaire, Ireland, incorporating the latest digital advancements in alignment with Industry 4.0 / Smart Manufacturing principles.
This role will be accountable for developing and continuously aligning the site manufacturing data ecosystem with rapidly changing business needs and Amgen technical roadmaps. They will lead complex and exciting IS & Automation initiatives that require understanding of analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.
This role is required to possess strong domain expertise in Manufacturing automation systems, Information/Data Management and technical experience in database and data historian technologies and integration tools. This candidate is expected be proficient and enthusiastic in the areas of Industry 4.0 / Smart Manufacturing and leveraging data and digital technologies to transform manufacturing operations.

Responsibilities:

• Own and shape the design and technology of the Digital, Technology and Innovation (DTI) ecosystem.
• Lead the execution of a varied portfolio of DTI and Automation projects with appropriate portfolio planning, resource, risk management and financial management for the portfolio.
• Shape Amgen’s future – Keep track of industry and technology trends, connect and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry.
• Perform cross system analysis, feasibility analysis, scope projects, prioritise deliverables, and recommend optimal solution. Manage multiple initiatives and priorities.
• Effectively manage relationships with DTI service owners, business partners, enterprise DTI service partners, and vendors.
• Communicate with multiple levels within the organisation, highlighting issues and proposing solutions.
• Accountable to elicit and analyse needs identified by business stakeholders and convert them into functional design.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Travel: Domestic and international travel as required to support projects.

BASIC QUALIFICATIONS:

• Doctorate degree and 2 years of information systems or engineering experience

Or

• Master’s degree and 6 years of information systems or engineering experience

Or

• Bachelor’s degree and 8 years of information systems or engineering experience

PREFERRED QUALIFICATIONS:

• Bachelor’s Degree in Engineering or Information Systems
• 8+ years’ experience in a manufacturing environment with 5+ years of demonstrated ability in the Pharmaceutical or Biotechnology industries
• 5+ years’ combined experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Siemens automaton platform, Rockwell Automation platform, Systech Serialization platform, Warehouse, and/or laboratory systems and/or IS platforms
• Experience and understanding of Filling and/or packaging machines (e.g. B&S, Optima)
• Understanding of Filling, Buffer, Formulation, Cleaning in place and Cleaning out of place processes
• Experience and understanding of Information Systems infrastructure services, fundamentals and operations (Storage, VMs, Network, Active Directory, etc.)
• Experience in methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping)
• Experience working with Agile development methodologies (such as Sprint and Scrum) and DevOps
• 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
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise
• Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies to establish a PCS and MES implementation and Systems Integration that meets Operations’ business requirements
• Familiarity with industry standards for software development life cycle methodologies and 21 CFR Part 11
• Experience with validation and change control methodology
• Hands-on experience with computerised systems including troubleshooting, reliability and performance improvements
• Effective verbal and written communication skills
• Strong interpersonal skills with ability to work collaboratively in a team-based environment
• Ability to lead multiple tasks and effectively set priorities
• Strong computer skills and possess the ability to apply science-based thinking to practical applications
• Energetic, innovative and technically-minded individual who likes to work in teams!
  We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.
  Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do

• Own and shape the design and technology of the Digital, Technology and Innovation (DTI) ecosystem.
• Lead the execution of a varied portfolio of DTI and Automation projects with appropriate portfolio planning, resource, risk management and financial management for the portfolio.
• Shape Amgen’s future – Keep track of industry and technology trends, connect and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry.
• Perform cross system analysis, feasibility analysis, scope projects, prioritise deliverables, and recommend optimal solution. Manage multiple initiatives and priorities.
• Effectively manage relationships with DTI service owners, business partners, enterprise DTI service partners, and vendors.
• Communicate with multiple levels within the organisation, highlighting issues and proposing solutions.
• Accountable to elicit and analyse needs identified by business stakeholders and convert them into functional design.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Travel: Domestic and international travel as required to support projects