# Senior Engineer - Drug Substance Equipment and Reliability

**Company:** [BioPharma Consulting JAD Group](https://jobs.workable.com/companies/pScfjBzGATtPx3geL93jwD.md)
**Location:** Juncos, Puerto Rico
**Workplace:** on site
**Employment type:** Contract
**Department:** Amgen

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## Description

Own drug substance manufacturing equipment and systems at a leading biotechnology company in Juncos, Puerto Rico. Three openings.

**What you'll do**

-   Perform system owner and engineering impact assessments for equipment failures, deviations and quality events.
-   Support technical investigations, identify failure mechanisms and develop CAPAs; apply lessons learned across equipment and areas.
-   Manage engineering work in IBM Maximo: work order technical review, pre- and post-approval, coordination and closure.
-   Develop and revise preventive maintenance strategies, job plans, inspection requirements and SOPs.
-   Lead troubleshooting, repairs, obsolete equipment replacement, spare parts evaluations and modernization projects.
-   Implement engineering controls and actions for safety incidents.

## Requirements

-   Bachelor's in Chemical, Mechanical or Electrical Engineering + 4 years (or Master's + 2, or Doctorate).
-   Manufacturing equipment support in pharma/biotech: centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers and instrumentation.
-   Investigations, CAPA and technical report writing.
-   IBM Maximo or similar CMMS.
-   Able to manage multiple assignments and work with Manufacturing, Maintenance, Quality, Automation, Validation and suppliers.

## Benefits

-   Contract: 6 months, with possible extension
-   Shift: Administrative, Monday–Friday