Automation Lead

AMTSOL•Barceloneta, PR

3d•Hybrid

About The Position

AMTSOL partners with global pharmaceutical and biotechnology organizations to deliver Automation, MES, CSV, CQV, and Digital Transformation solutions across Singapore, Europe, and the USA. We are looking for an experienced Automation Lead to drive automation delivery project at a biopharmaceutical manufacturing site in Puerto Rico. This is a hands-on leadership role covering end-to-end automation delivery including design, configuration, integration, testing, and commissioning within a regulated Life Sciences environment. The role places strong emphasis on automation panel hardware and software delivery, automation lifecycle governance, cross-functional coordination, and stakeholder management — ensuring alignment with project timelines, compliance standards, and data integrity requirements. The role is based on a hybrid schedule, split between onsite presence in Puerto Rico and remote work.

Requirements

Bachelor's degree in Engineering (Automation, Control Systems, Chemical, or related field)
Strong, hands-on automation project experience — configuration, integration, and commissioning (essential)
Proven experience delivering automation for biopharma manufacturing facilities
Experience with brownfield/capacity-expansion projects preferred
Solid understanding 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 commissioning & qualification (CQV) activities
Experience working with cross-functional teams across Process, Manufacturing, QA, IT, and Engineering
Strong vendor and system-integrator management skills
Excellent stakeholder management and communication skills
Ability to manage multiple priorities in a fast-paced project environment, working in a hybrid arrangement based in Puerto Rico

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 & qualification (CQV) activities
Coordinate with cross-functional teams including Process, Engineering, Manufacturing, Quality, 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
Track and mitigate automation risks, issues, and dependencies proactively
Manage stakeholder communication, ensuring clear visibility on automation progress, risks, and deliverables
Oversee change control, documentation, and data integrity within GxP environments