# QC Microbiology Specialist - Method Validation and NPI

> BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-11-13

**Workplace:** on_site

**Department:** Amgen

## Description

Be the technical specialist for the microbiology lab at a leading biotechnology company in Juncos, Puerto Rico, supporting method validations for new product introductions.

**What you'll do**

-   Write microbiology method validation (MMV) protocols and reports for new product introductions.
-   Provide technical support to the microbiology lab: bioburden, endotoxin, low endotoxin recovery, sterility and mycoplasma testing.
-   Design special studies and troubleshoot assays.
-   Support deviation owners in evaluating events and root causes; approve lab investigations.
-   Develop, revise and audit controlled documents and support lab compliance with GMP/GLP.

## Requirements

-   Bachelor's + 4 years (or Master's + 2, or Doctorate) of directly related experience; microbiology background preferred.
-   Microbiology method validation and technical writing.
-   Bioburden, endotoxin (including low endotoxin recovery), sterility, MMV and mycoplasma testing.
-   Strong knowledge of GMPs/CFRs and U.S. regulations for testing biological products.
-   Data analysis, trending and complex problem solving.
-   Bilingual English/Spanish preferred.

## Benefits

-   Contract: 2.5 months, with possible extension
-   Shift: Administrative, Monday–Friday 8:00 am–5:00 pm (overtime upon business needs)

## Apply

[Apply at BioPharma Consulting JAD Group](https://apply.workable.com/biopharma-consulting-jad-group/j/97A161B605/apply)

---
Powered by [Workable](https://www.workable.com)