Principal Process Scientist

Weil Group • Area Norte, PR

6d • Onsite

About The Position

We are seeking a Principal Process Scientist to provide specialized technical support to a Sterile Manufacturing site, with focus on sterile manufacturing processes, process science, liquid and lyophilized parenteral products, process validation, troubleshooting, technology transfers, and continuous improvement. This role will serve as a Subject Matter Expert supporting daily manufacturing operations, deviation investigations, CAPA development, process monitoring, validation activities, and process optimization initiatives. The resource will also support technology transfer projects, new product introductions, and lifecycle management activities to ensure robust, compliant, and efficient manufacturing processes. The resource will collaborate with Manufacturing, Engineering, Quality, Validation, MS&T, and other cross-functional teams to resolve technical issues, support risk assessments and change controls, and ensure alignment with cGMP requirements, site procedures, regulatory expectations, and business priorities.

Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biotechnology, Life Sciences, or related technical field.
• 10+ years of experience in pharmaceutical, biotechnology, sterile manufacturing, or parenteral operations.
• Strong experience in process science, aseptic manufacturing, liquid and lyophilized parenteral products, process validation, technology transfer, troubleshooting, deviation investigations, CAPA, change control, process monitoring, and process optimization.

Nice To Haves

• Master’s degree or Ph.D. in a related discipline.
• Experience with cGMP documentation, regulatory inspections, audit readiness, and cross-functional technical leadership.

Responsibilities

• Provide specialized technical support to a Sterile Manufacturing site.
• Focus on sterile manufacturing processes, process science, liquid and lyophilized parenteral products, process validation, troubleshooting, technology transfers, and continuous improvement.
• Serve as a Subject Matter Expert supporting daily manufacturing operations, deviation investigations, CAPA development, process monitoring, validation activities, and process optimization initiatives.
• Support technology transfer projects, new product introductions, and lifecycle management activities.
• Collaborate with Manufacturing, Engineering, Quality, Validation, MS&T, and other cross-functional teams to resolve technical issues, support risk assessments and change controls, and ensure alignment with cGMP requirements, site procedures, regulatory expectations, and business priorities.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal