Principal Process Scientist
Title: Principal Process Scientist
Location: Manati, Puerto Rico (Open to Puerto Rico Residents)
Onsite work
Positions: 1
Summary:
Principal Process Scientist with extensive expertise supporting sterile manufacturing operations in FDA-regulated pharmaceutical environments. Recognized as a Subject Matter Expert in aseptic processing, liquid and lyophilized parenteral manufacturing, and process troubleshooting. Proven ability to support daily manufacturing operations, lead complex investigations involving deviations and CAPAs, and drive timely resolution of technical and quality issues. Experienced in process validation, technology transfer, and process optimization initiatives that improve operational efficiency, product quality, and regulatory compliance. Strong knowledge of cGMP requirements, aseptic manufacturing standards, and site quality systems. Adept at collaborating cross-functionally with Manufacturing, Quality, Engineering, and Validation teams to ensure seamless execution of production and compliance activities. Demonstrated ability to analyze process data, identify improvement opportunities, and implement sustainable corrective actions. Committed to maintaining the highest standards of product quality, patient safety, and operational excellence within sterile pharmaceutical manufacturing operations.
Responsibilities include:
- Supporting daily manufacturing operations
- Troubleshooting and leading investigations (e.g., deviations and CAPAs)
- Supporting process validation activities
- Contributing to technology transfer and process optimization efforts
- Ensuring compliance with cGMP regulations and site procedures