Process Development & Validation Scientist

Responsibilities

• Design, execute, monitor, and interpret scientific studies supporting process development and manufacturing operations
• Support process characterization, optimization, scale-up, technology transfer, and validation activities
• Analyze data, identify trends, and recommend process improvements
• Troubleshoot technical issues and support deviations, investigations, and root cause analyses
• Prepare protocols, technical reports, validation documentation, and summary documents
• Collaborate with Manufacturing, Quality, Engineering, Validation, and Process Development teams
• Support commercial manufacturing, inspection readiness, and regulatory audit activities

Requirements

• Doctorate degree, or Master's degree with 2+ years of scientific experience, or Bachelor's degree with 4+ years of scientific experience
• Knowledge of GMP regulations and regulated manufacturing environments
• Strong technical writing and documentation skills
• Advanced analytical, troubleshooting, and problem-solving skills
• Proficiency with Microsoft Office applications
• Effective communication and ability to work in cross-functional teams

Preferred Qualifications

• Experience supporting drug product manufacturing in a regulated environment
• Experience with process validation, protocol development, execution, and reporting
• Experience authoring scientific reports and validation documents
• Knowledge of process characterization and technology transfer
• Bilingual proficiency in English and Spanish

Benefits

• 6-month contract with possible extension
• Administrative shift
• On-site role in Juncos, Puerto Rico