Amgen Specialist IS Architect - DCS in Thousand Oaks, California
Reporting to the OIS Sr. Manager of Manufacturing Solution Architecture this Information Systems Leader is accountable for delivering Platform Management and Solution Architecture services in the area of DCS Process Automation. The role is responsible for supporting global project portfolio execution, global technology initiatives as well as relationship management of key technology suppliers.
This role is accountable for developing a multi-year roadmap for the DCS platform aligned with global site and corporate priorities. This role ensures that the DCS platform continuously improve and will ensure that the voice of the customer is incorporated into strategic direction. This individual will represent Amgen at various internal network teams and external industry forums. Travel at various times is anticipated to support globally project portfolio execution.
Define the lifecycle roadmap for the DCS platform.
Ensure global licensing and maintenance agreements are in place for the DCS platform.
Support delivery of capital projects in partnership with the OIS project delivery team.
Develop and mentor the site based platform system owners.
Provide input into the design of capital projects.
Identify and qualify system and solution providers.
Own global architectural standards for the implementation of DCS systems.
Supports implementation of global transformational initiatives.
Support Amgen global DCS Service owner and business units with required IS Solutions and platforms.
Any other tasks/projects assigned as per manager's request.
Basic Qualifications & Experience:
Master's degree & 3 years of directly related experience
Bachelor's degree & 5 years of directly related experience
Associate's degree & 10 years of directly related experience
High school diploma / GED & 12 years of directly related experience
Preferred Qualifications & Experience:
Bachelor's degree in Engineering, Information Systems, Computer Science or the Life Sciences.
10+ years' experience providing process control and information systems solutions and support to manufacturing organizations in the biotechnology or pharmaceutical industries.
DCS project execution and/or support experience in biopharmaceutical Formulation/Fill/Finish and Active Pharmaceutical Ingredient (API) facilities.
Working knowledge of FDA cGxP and 21 CFR Part 11 regulations and software system validation.
Working knowledge and application of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards in successful execution of appropriate development methodologies
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.
Ability to lead virtual teams.
Ability to build cohesive teams of employees and consultants.
Customer relationship management skills.
Critical thinking skills.
Experience in other areas of Information Systems supporting manufacturing business units in IT infrastructure and business systems.
Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.
Strong technical and organizational communication, coordination, and meeting facilitation skills.
Day to day vendor management and contract negotiations with focus on DCS solution providers.
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 issues, delays and problems by utilizing technical, project management, and business expertise.
Ability to enhance and apply corporate blueprint and standards using business drivers to local business needs and project requirements.
Ability to develop, and present business cases, project plans, and updates to senior management.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.