Senior Engineer - Equipment Technical Assessments

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

BioPharma Consulting JAD Group in Juncos, Puerto Rico, seeks an engineer to evaluate drug substance equipment and write technical assessments that support qualification across purification, fermentation and utilities.

You will write engineering assessments and technical justifications, review drawings and vendor documents, evaluate failures and maintenance history, and support deviations, CAPAs and change controls on a Monday–Friday, on-site basis.

Qualifications

• cGMP and inspection-ready technical writing.
• Equipment-specific investigations on purification, fermentation, process equipment or utilities.
• Review drawings, vendor documents, work orders and calibration records; inspect equipment in the field.

Responsibilities

• 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.

Skills

Engineering knowledge

Analytical thinking

Technical writing

Education

Bachelor's degree in Engineering

Tools

cGMP

Regulatory compliance

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.

• 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.

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