Sr Engineer - Equipment Technical Assessments

We are seeking a Senior Engineer to support Drug Substance Facilities and Engineering at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. This role independently performs technical assessments of manufacturing equipment and systems, and applies advanced engineering principles to process optimization, troubleshooting and system modifications of significant scope and complexity.

Key Responsibilities

• Prepare, review and approve technical reports, engineering assessments, equipment evaluations and technical justifications.
• Evaluate equipment failures, performance issues, maintenance history and operating conditions, and their potential impact on product, process, quality and qualified state.
• Provide technical support for deviations, investigations, CAPAs, change controls, risk assessments and regulatory commitments.