Position Summary:
Responsible for supporting manufacturing operations through technical investigations, process monitoring, documentation review, and continuous improvement initiatives within a regulated biopharmaceutical environment. The role requires collaboration across Manufacturing, Process Development, Quality, and other cross-functional teams to ensure compliance, product quality, and operational excellence.
Key Responsibilities:
• Support manufacturing operations and bio-processing unit operations activities.
• Conduct and support investigations, deviations, and root cause analyses.
• Monitor manufacturing processes and identify opportunities for continuous improvement.
• Collaborate with cross-functional teams including Manufacturing, Process Development, Quality, and Engineering.
• Prepare, review, and maintain technical documentation in compliance with Good Documentation Practices (GDP).
• Analyze process data and trends using available systems and monitoring tools.
• Support Lean Manufacturing and operational excellence initiatives.
• Prepare technical reports,



presentations, and documentation for management review.
• Ensure compliance with applicable regulations, procedures, and quality standards.

Required Qualifications:
• Bachelor's Degree in Engineering, Biotechnology, Life Sciences, Microbiology, Chemistry, or a related scientific discipline.
• Experience in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment.
• Strong written and verbal communication skills in English and Spanish.
• Proficiency in technical writing and presentation development.
• Ability to work effectively in a team-based environment.
• Excellent interpersonal and collaboration skills.
• Ability to work independently with minimal supervision.
• Availability to work under high workload conditions and extended hours when required.

Preferred Qualifications:
• Experience in bio-processing unit operations.
• Knowledge of Root Cause Analysis (RCA) me

📌 Sr. Investigator Specialist (Juncosa)
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📍 Juncosa