Process Lead - Puerto Rico (Onsite)

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.

Process Lead – Life Sciences

• Role : Process Lead
• Location: Puerto Rico (Onsite)
• 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 Process Lead to own the process engineering expansion project at a biopharmaceutical manufacturing site in Puerto Rico. This is a hands-on leadership role covering process design, equipment specification, and coordination through to execution and qualification within a regulated Life Sciences environment.

The role places strong emphasis on process system design, cross-functional coordination with automation and engineering teams, and stakeholder management — ensuring alignment with project timelines, compliance standards, and quality requirements. The role is based onsite in Puerto Rico.

Key Responsibilities

• Own the process engineering scope for the project, including process system design and sizing
• Define equipment and system requirements in line with process needs
• Coordinate process input into equipment specification alongside the Automation Lead (hardware and software)
• Support design reviews and key process-related decisions
• Coordinate with cross-functional teams including Automation, Engineering, Manufacturing, and Quality
• Support FAT, SAT, and commissioning & qualification (CQV) activities from a process perspective
• Ensure adherence to GxP and applicable regulatory frameworks throughout the process lifecycle
• Track and mitigate process-related risks, issues, and dependencies proactively
• Provide clear visibility on process design progress, risks, and deliverables to project leadership
• Support change control and documentation within GxP environments

Requirements

• Bachelor's degree in Engineering (Process, Chemical, Biochemical, or related field)
• Strong, hands-on process engineering experience in biopharma manufacturing (essential)
• Proven experience delivering process scope for drug substance / biologics manufacturing facilities
• Experience with brownfield/capacity-expansion projects preferred
• Solid understanding of GxP environments and regulatory frameworks (GMP / GAMP5)
• Experience coordinating with automation and engineering teams on system design
• Experience supporting FAT, SAT, and commissioning & qualification (CQV) activities
• Experience working with cross-functional teams across Automation, Manufacturing, QA, and Engineering
• Excellent stakeholder management and communication skills
• Ability to manage multiple priorities in a fast-paced project environment, working onsite in Puerto Rico