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Senior Engineer - Equipment Technical Assessments

Job Description - Senior Engineer - Equipment Technical Assessments

Description

Be the engineer who evaluates drug substance equipment and writes the technical assessments that keep it qualified, across purification, fermentation and utilities, at a leading biotechnology company in Juncos, Puerto Rico.

What you'll do

  • Write engineering assessments, equipment evaluations and technical justifications.
  • Evaluate failures, performance and maintenance history, including impact on product 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.


Requirements
  • Bachelor's degree in Engineering + 4 years in pharma/biotech manufacturing.
  • Equipment-specific investigations on purification, fermentation, process equipment or utilities.
  • cGMP and inspection-ready technical writing.


Benefits
  • Contract: 13 months, with possible extension
  • Shift: Administrative, Monday–Friday
  • Start: Immediate
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