Automation Lead – Biopharma (Hybrid)

Advanced Manufacturing Tech Solutions; Barceloneta (PR); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Advanced Manufacturing Tech Solutions seeks an experienced Automation Lead for a biopharmaceutical site in Puerto Rico. The role covers end-to-end automation delivery, including hardware and software, with an emphasis on lifecycle governance in a regulated Life Sciences setting.

You will lead cross-functional teams, coordinate validation activities, and ensure data integrity and regulatory compliance while working in a hybrid schedule (onsite in Puerto Rico and remote).

Qualifications

• Bachelor's degree in Engineering (Automation/Control/Chemical) or related field.
• Hands-on automation project experience — configuration, integration, and commissioning.
• Proven experience delivering automation for biopharma manufacturing facilities.
• Brownfield/capacity-expansion project experience preferred.
• Strong knowledge of GxP environments and regulatory frameworks (GMP/GAMP5/21 CFR Part 11).
• Experience integrating automation platforms with MES, historians, and other manufacturing systems.
• Experience leading FAT, SAT, and CQV activities.
• Experience collaborating with Process, Manufacturing, QA, IT, and Engineering teams.

Responsibilities

• Lead end-to-end automation delivery for the project, including panel hardware (H/W) and software (S/W) scope.
• Own the automation lifecycle — design, configuration, integration, testing, and commissioning.
• Develop and manage automation project plans, schedules, and milestones.
• Define automation scope across process and equipment systems.
• Drive system integration between automation platforms and other manufacturing systems as required.
• Lead automation design reviews, FAT, SAT, and commissioning & CQV activities.
• Coordinate with cross-functional teams including Process, Engineering, Manufacturing, QA, IT, and Validation.
• Manage automation vendors, system integrators, and third-party deliverables.
• Ensure adherence to GxP, GAMP5, and 21 CFR Part 11 across the automation lifecycle.

Skills

Automation leadership

Panel hardware delivery

Platform integration

Cross-functional coordination

Stakeholder management

Regulatory compliance

Education

Bachelor's degree in Engineering (Automation/Control/Chemical)

Tools

MES systems

Historians

Job description

Advanced Manufacturing Tech Solutions seeks an experienced Automation Lead for a biopharmaceutical site in Puerto Rico. The role covers end-to-end automation delivery, including hardware and software, with an emphasis on lifecycle governance in a regulated Life Sciences setting.

You will lead cross-functional teams, coordinate validation activities, and ensure data integrity and regulatory compliance while working in a hybrid schedule (onsite in Puerto Rico and remote).