Sr. Systems Engineer - Project Delivery Lead

Amgen•Juncos, PR

About The Position

The Sr. Systems Engineer - Project Delivery Lead will lead the digital transformation of manufacturing systems, advancing innovation, compliance, and operational excellence through automation and smart technologies. The role serves as a subject matter expert in manufacturing systems and digital technologies and leads implementation and integration of MES, SCADA, Industry 4.0 solutions, and other manufacturing IT systems. The position develops budgetary cost estimates for technology scopes of capital projects; collaborates with cross-functional teams to define system requirements; and creates system documentation such as user requirements, design specifications, and test plans. It also troubleshoots systems and coordinates resolution with IT and vendor support teams, ensures compliance with cGMP, data integrity, and cybersecurity requirements, and supports commissioning, qualification, validation, and change control. The role trains users, supports audits and inspections with system documentation, monitors new manufacturing technologies and digital trends, and promotes digital innovation and operational excellence.

Requirements

Doctorate degree in Engineering; or a master's degree in Engineering and 2 years of Manufacturing Systems/Automation experience; or a bachelor's degree in Engineering and 4 years of Manufacturing Systems/Automation experience.
Knowledge and/or experience of pharmaceutical or biotech processes, especially inspection or packaging operations.
Organizational, project management, and problem-solving capability.
Knowledge of data integrity and cybersecurity.
Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.
Expertise in databases.
Expertise in the Rockwell software platform.
Direct experience with Systech Serialization projects, including Guardian, Advisor, Sentri, and other Systech ancillary devices.
Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment.
Comprehensive understanding of validation protocol execution requirements and validation processes and requirements for new equipment installations.
Excellent verbal and written communication skills and demonstrated ability to work in a team environment.
Proven track record of leading and executing cross-functional projects.
Strong teamwork, interpersonal, and communication skills.
Direct experience with medical devices or combination products and associated manufacturing processes.
Experience working with third-party vendors and equipment suppliers.
Ability to work in a highly regulated and ever-changing industry.
Ability to learn and rapidly adapt to new requirements in a fast-moving environment.
An Operational Excellence and Lean Transformation approach to work product, driving rapid results.

Nice To Haves

Advanced degree in Computer, Electrical, Mechanical, Chemical, or Biomedical Engineering.
Expertise in Machine Vision (Cognex) is preferred.

Responsibilities

Serve as a subject matter expert in manufacturing systems and digital technologies.
Lead implementation and integration of MES, SCADA, Industry 4.0 solutions, and other manufacturing IT systems.
Lead development of budgetary cost estimates for the technology scope of capital projects.
Collaborate with multifunctional teams to define system requirements and align them with business needs.
Develop system documentation, including user requirements, design specifications, and test plans.
Troubleshoot system issues and coordinate resolution with IT and vendor support teams.
Ensure system compliance with cGMP, data integrity, and cybersecurity requirements.
Support system commissioning and qualification, validation, and change control activities.
Train users on system functionality and best practices.
Participate in audits and inspections, providing system documentation and support.
Stay informed about new technologies and digital trends in manufacturing.
Promote a culture of digital innovation and operational excellence.

Benefits

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Discretionary annual bonus program.
Stock-based long-term incentives.
Award-winning time-off plans and an annual site shutdown.
Flexible work models where possible.