Sr. Systems Engineer - Project Delivery Lead (Manufacturing Systems)

Location: On-site in Juncos, Puerto Rico, United States.

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses.

What you will do

• Lead the digital transformation of manufacturing systems through automation, smart technologies, MES, SCADA, Industry 4.0, and other manufacturing IT solutions.
• Act as a subject matter expert and lead system implementation and integration activities.
• Define system requirements with cross-functional teams and develop cost estimates for technology scopes of capital projects.
• Prepare user requirements, design specifications, test plans, and other system documentation.
• Troubleshoot system issues, coordinate resolution with IT and vendors, and support user training.
• Support cGMP compliance, data integrity, cybersecurity, commissioning, qualification, validation, change control, audits, and inspections.

Requirements

• Doctorate degree in Engineering, or a master’s degree in Engineering plus 2 years of Manufacturing Systems/Automation experience, or a bachelor’s degree in Engineering plus 4 years of Manufacturing Systems/Automation experience.

Nice to have

• Advanced degree in Computer, Electrical, Mechanical, Chemical, or Biomedical Engineering.
• Knowledge or experience with pharmaceutical or biotech processes, especially inspection or packaging operations.
• Organizational, project management, and problem-solving skills.
• Knowledge of data integrity and cybersecurity.
• Experience with programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.
• Expertise in databases, the Rockwell software platform, and Machine Vision using Cognex.
• Direct experience with Systech Serialization projects, including Guardian, Advisor, Sentri, and related Systech devices.
• Ability to interpret and apply GAMPs and GMPs and work with documentation in a highly regulated environment.
• Understanding of validation protocol execution and validation requirements for new equipment installations.
• Strong verbal and written communication, teamwork, interpersonal, project leadership, and cross-functional collaboration skills.
• 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, changing industry and rapidly adapt to new requirements.
• Operational Excellence and Lean Transformation approach focused on rapid results.

Culture & Benefits

• Health, dental, vision, life, and disability insurance.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time off plans and an annual site shutdown.
• Career development opportunities and work-life balance support.

Hiring process

• Sponsorship for this role is not guaranteed.