Principal Manufacturing Systems Engineer - Amgen North Carolina Site Lead

Amgen • Holly Springs, NC

5d

About The Position

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. In this vital role you will be part of Amgen's most technologically advanced drug substance manufacturing plant. The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide.

Requirements

• Doctorate degree and 2 Information Systems, Manufacturing Process automation/Information system experience OR Master's degree and 4 Information Systems, Manufacturing Process automation/Information system experience ; OR Bachelor's degree and 6 Information Systems, Manufacturing Process automation/Information system experience ; OR Associate's degree and 10 Information Systems, Manufacturing Process automation/Information system experience; OR High school diploma / GED and 12 years of Information Systems, Manufacturing Process automation/Information system experience

Nice To Haves

• Demonstrable experience in a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries.
• Experience with the following product platforms: Automation/Process Control System (PCS), Data Historian and/or Manufacturing Execution System (MES) and/or laboratory systems and/or IS platforms.
• Position requires an in-depth knowledge and hands-on coding experience of Emerson Delta V Platform in particular, and on Rockwell FactoryTalk, Rockwell PLC’s.
• Aveva PI Data Historian knowledge is required.
• Kneat platform based C&Q documentation development knowledge a plus
• Additional experience with Korber MES is a plus.
• Demonstrable 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.
• Exposure to sophisticated technologies around PAT, APC, AR/VR, Location tracking, Control tower, IIoT, IDA and so on would be an advantage.
• 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 computerized systems including troubleshooting, reliability and performance improvements.
• Good interpersonal skills with ability to work collaboratively in a team-based environment.
• Understanding of cyber security and manufacturing network principles as applied to operations technologies.
• Demonstrate ability to lead and influence multi-functional teams and embrace a team-based culture.

Responsibilities

• Own the successful delivery of varied portfolio of IS/Automation projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by using technical, project management, and business expertise.
• Performs cross system assessments, feasibility analysis, scope projects, prioritize work you're doing, 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 customers and convert them into functional design.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: No Education Listed