Amgen Senior Manager - Automation in Dublin, Ireland
Senior Manager - Automation
Amgen Dun Laoghaire
The Senior Manager will act as the automation project leader for site projects and will report to the Head of Automation. The Senior Manager will influence the development of business area strategy where appropriate. Travel at various times is anticipated to support execution of projects.
The Senior Manager will demonstrate project engineering skills, including but not limited to the following: client interfacing and resolution of client concerns, developing and reporting project results, technical guidance of a project from concept to delivery, detailed project planning, management of suppliers/contractors/Systems integrators/OEMs, system commissioning and validation, technical solution evaluation, schedule tracking, budget management.
End-to-end delivery of Automation scope for Site Projects, Automation System Lifecycle Projects and continuous improvement initiatives.
Build consensus between the individual requirements of operations, Corporate Engineering, OIS, and corporate standard architectures to design the project specific automation architecture for project activities.
Provide technical leadership to projects through all project phases (design, delivery, startup, commissioning, validation and operational support) as well as day to day automation project management oversight to ensure the project budgets, schedules and staffing are appropriate to enable project success.
Define consistent computer systems validation deliverables aligned with local ang global governing procedures.
Ensuring alignment of solutions with Amgen and industry standards and regulations as they pertain to systems and system architectures.
Active engagement with site capital project teams, Operations IS & Automation to ensure projects are appropriately scoped and coordinated, and that solutions delivered are robust, reliable and maintainable.
Ensure appropriate and timely escalation of project issues and risks to Head of Automation.
Evolution and continuous improvement of project delivery processes to ensure consistency, efficiency and quality, employing LEAN practices as appropriate.
Active member of the Automation management team, contributing to and supporting the overall Site Support strategy and functional deliverables.
Any other tasks/projects assigned as per manager’s request.
Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.
Be part of a learning and development programme which will include goal setting, annual performance reviews and individual development plans.
Be a champion for safe working practices and safety initiatives within their functional area.
Basic Qualifications & Experience:
Bachelors degree in Engineering, Information Systems, Computer Science or the Life Sciences.
At least 10 years experience providing process control and information systems solutions and support to manufacturing organisations in the biotechnology or pharmaceutical industries.
Demonstrated leadership skills.
Experience directing the activity of others in matrix, internal or external reporting relationships.
Experience dealing with a large project portfolio in the areas of Information Systems, Automation and Manufacturing Operations.
Experience engaging with and providing updates to executive management.
Project Management Qualification.
Preferred Qualifications & Experience:
Significant experience in the delivery and management of automated systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and appropriate development methodologies for process and utility control systems.
Candidates will have worked on automation systems in cGMP regulated manufacturing environments, preferably in Formulation/Fill/Finish, and will be knowledgeable regarding FDA cGxP and 21 CFR Part 11 regulations and understand software system validation. Experience with Rockwell Automation PLC/SCADA/Batch, Siemens S7, GE iFix, OSIsoft PI Data Historian, Werum PAS|X MES, COPA-DATA Zenon SCADA and Siemens BAS is advantageous. Experience in other areas of Information Systems supporting manufacturing business unit is a plus.
Ability to build teams and operate across functional boundaries, both internal and external.
Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
Ability to work independently and remotely with minimum direct supervision
Resource, mentoring and performance management skills
Ability to build cohesive teams of employees and consultants
Customer relationship management skills
Critical thinking skills
Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.
Strong technical and organisational communication, coordination, and meeting facilitation skills.
Day to day vendor management and contract negotiations with focus on Automation Systems Integrators and OEM suppliers.
Technical Oversight of all automation project phases including design, development, implementation, testing, construction, commissioning, and validation.
Development and presentation of execution plans and strategies to senior management.
Ensuring compliance with practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies, develop supporting documentation and monitor budget tracking/ timeliness/ scheduled resources.
Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
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 quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.