Biopharma Automation Lead — End-to-End Delivery (Hybrid PR)

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

Job summary

AMTSOL is seeking an experienced Automation Lead for a 12-month Life Sciences project in Puerto Rico. The role covers end-to-end automation delivery, including design, configuration, integration, testing, and commissioning within a regulated environment.

The candidate will lead hardware and software scope, ensure lifecycle governance, and coordinate with Process, Engineering, Manufacturing, QA, IT, and Validation to meet timelines and data integrity requirements.

Qualifications

• Hands-on automation project leadership essential.
• Strong ability to coordinate across Process, Engineering, Manufacturing, QA, IT and Validation.
• Solid understanding of GMP, GAMP5, and 21 CFR Part 11.

Responsibilities

• Lead end-to-end automation delivery for the project, including panel hardware and software 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 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 and data integrity across the lifecycle.

Skills

Automation leadership

Cross-functional

GxP knowledge

CQV expertise

Vendor management

Hybrid coordination

Education

Bachelor's in Engineering

Job description

A leader in Life Sciences Manufacturing Technology solutions, AMTSOL partners with global pharmaceutical and biotechnology organizations to deliver Automation, MES, CSV, CQV, and Digital Transformation solutions across Singapore, Europe, and the USA.

Automation Lead – Life Sciences

• Location: Puerto Rico (Hybrid – 50% Onsite / 50% Remote)
• Industry: Pharmaceutical / Biotech Manufacturing
• Duration: 12 months (initial)
• Rates: Open, aligned with skills and experience
• Selection Process: 2 rounds of discussion
  
  
  

Overview

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.

Key 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
  
  
  

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