Biopharma Process Lead, Onsite Puerto Rico

Advanced Manufacturing Tech Solutions; Barceloneta (PR); On-site; USD 100,000 - 140,000; Full time

Job summary

AMTSOL, a leader in Life Sciences Manufacturing Technology, seeks an experienced Process Lead to own the process engineering expansion project at a biopharmaceutical site in Puerto Rico. This hands-on leadership role covers process design, equipment specification, and coordination through execution and qualification within a regulated Life Sciences environment.

The role emphasizes cross‑functional coordination with Automation, Engineering, Manufacturing, and Quality, strong stakeholder

Qualifications

• Bachelor's degree in Engineering or related field required.
• Strong hands‑on process engineering experience in biopharma manufacturing.
• Experience delivering process scope for drug substance/biologics facilities preferred.

Responsibilities

• Own the process engineering scope for the project, including process 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 visibility on process design progress, risks, and deliverables to project leadership.
• Support change control and documentation within GxP environments.

Skills

Process engineering

Cross‑functional coordination

Stakeholder management

Onsite presence

Education

Bachelor's degree in Engineering

Job description

AMTSOL, a leader in Life Sciences Manufacturing Technology, seeks an experienced Process Lead to own the process engineering expansion project at a biopharmaceutical site in Puerto Rico. This hands-on leadership role covers process design, equipment specification, and coordination through execution and qualification within a regulated Life Sciences environment.

The role emphasizes cross‑functional coordination with Automation, Engineering, Manufacturing, and Quality, strong stakeholder