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 demonstrates its 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.
As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance.
Amgen is seeking an IS Engineer, internally known Sr Associate IS (Information Systems) Engineer, in our Woburn facility to join our team. As a member of the team, the Sr Associate will support complex and exciting process IS/automation initiatives that require understanding of analytical problem-solving techniques, project management, lifecycle management and Operational Excellence. Additionally, the Sr Associate provides project and daily operational support.Responsibilities
- Deliver technical oversight to application delivery for the business.
- Ensure that systems are implemented and maintained in compliance with 21 CFR Part 11 and follows the IS Project Management Lifecycle Methodology.
- Coordination of business process and system issues across multiple departments, functions and locations.
- Lead technical root cause analysis, incident investigations, business case development and troubleshooting on computerized systems.
- Analyze problems, develop and propose technical solutions in a scientific manner using data-driven techniques and analyses.
- Assists technical root cause analysis, incident investigations, and solving problems on process control issues related to electrical, instrumentation and control systems.
- Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
- Works closely with multiple disciplines, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to support a diverse portfolio of projects.
- Provides technical support to commercial and clinical manufacturing.
- Develops and executes critical initiatives for long-range planning and lifecycle upgrades of various platforms with activities including developing roadmap of systems, presenting high level scope and cost estimates for annual capital funding plan, and project management of initiatives once approved for implementation.
- Communicates proactively with multiple levels within the organization, highlighting issues and proposing solutions.
- Technical support and issue resolution 24x7 on-call support of systems on a rotational based frequency.
- Applies experience and knowledge of industry standard methodologies and tools to attain an innovative organization.
Bachelor's degree and 2 years of Engineering or Information Systems experience
Associate's degree and 6 years of Engineering or Information Systems experience
High school diploma / GED and 8 years of Engineering or Information Systems experiencePreferred Qualifications
- Bachelor's degree in Engineering or Information Systems.
- 4+ years of experience with operations/manufacturing environment.
- Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.).
- Hands-on experience with computerized 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 manage multiple tasks and effectively set priorities.
- Sound understanding of basic engineering principles and ability to apply them to resolve process issues.
- Strong computer skills and possess the ability to apply science-based thinking to practical applications.
- Energetic and technically minded individual.
- Experience with validation and change control methodology.
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.
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.
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.