Senior Engineer - Equipment Technical Assessments

BioPharma Consulting JAD Group

20h • Onsite

About The Position

Evaluate drug substance equipment and prepare technical assessments to help maintain its qualified state at a biotechnology company in Juncos, Puerto Rico. The work covers purification, fermentation, process equipment, and utilities. The role involves assessing equipment failures, performance, and maintenance history, including potential impacts on products and qualification.

Requirements

• Bachelor's degree in Engineering.
• At least 4 years of experience in pharmaceutical or biotechnology manufacturing.
• Experience conducting equipment-specific investigations involving purification, fermentation, process equipment, or utilities.
• cGMP knowledge and inspection-ready technical writing skills.

Responsibilities

• Write engineering assessments, equipment evaluations, and technical justifications.
• Evaluate equipment failures, performance, and maintenance history, including their impact on products and qualified state.
• Support deviations, CAPAs, change controls, risk assessments, and regulatory commitments.
• Review drawings, vendor documents, work orders, and calibration records.
• Inspect equipment in the field.

What This Job Offers

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