BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

QC Microbiology Specialist - Method Validation and NPI

Regulatory & Quality (Life Sciences)Posted on Nov 13

Full-timeJuncos, Puerto RicoNo salary listed

About the Job

Requirements

A bachelor's degree with four years of directly related experience, a master's degree with two years of directly related experience, or a doctorate.
Microbiology method validation experience and technical writing skills.
Experience with bioburden, endotoxin (including low endotoxin recovery), sterility, microbiology method validation, and mycoplasma testing.
Strong knowledge of good manufacturing practices, good laboratory practices, Code of Federal Regulations, and U.S. regulations for testing biological products.
Data analysis, trending, and complex problem-solving skills.

Responsibilities

Write microbiology method validation protocols and reports for new product introductions.
Provide technical support to the microbiology lab for bioburden, endotoxin, low endotoxin recovery, sterility, and mycoplasma testing.
Design special studies and troubleshoot assays.
Support deviation owners in evaluating events and root causes, and approve lab investigations.
Develop, revise, and audit controlled documents, and support lab compliance with good manufacturing practices and good laboratory practices.

Desired Qualifications

A microbiology background.
Bilingual proficiency in English and Spanish.

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

About the Company

BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

BioPharma Consulting JAD Group advises pharmaceutical and biotechnology businesses on engineering, quality and regulatory compliance. It works with companies operating under US Food and Drug Administration rules to develop technical solutions for their manufacturing plants and processes. Its engineering practice covers facility and equipment design, process improvements and project management, while validation work verifies and documents that production systems meet requirements. The firm sells tailored consulting and technical support for assignments and projects, with company managers involved in delivery. Founded in 2010, it is headquartered in Cambridge, Massachusetts.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Cambridge, MA
Founded: 2010

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