Senior Engineer - Equipment Technical Assessments
BioPharma Consulting JAD Group
Job Description
Job 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
Vacancy posted 1 day ago
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