Microbiology Validation Engineer II – GMP & Compliance

Oxoid Remel Microbiology

Lenexa (KS)

On-site

USD 60,000 - 75,000

Full time

14 days+

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Benefits offered by this job

401k

Healthcare coverage

Vision coverage

Employee assistance program

Telehealth/24-7 virtual doctor visits

Job summary

Oxoid Remel Microbiology, part of a 100-year microbiology legacy, seeks a validation professional to qualify culture media and related diagnostic products. You will ensure compliance with 21CFR 820, ISO 13485, and drive investigations for abnormal results within a cross-functional quality team.

We offer extensive training, growth opportunities, and benefits including 401k, healthcare, vision coverage, and 24/7 virtual doctor visits.

Qualifications

Bachelor's degree in a science, engineering, or related field.
Preferred 1 year of Validation experience in a regulated environment.
Preferred experience with lean manufacturing tools and practices.

Responsibilities

Execute Validation studies in compliance with 21CFR part 820, ISO 13485, and other medical device industry standards.
Set, incubate, and read microbial media test results. (Including bacterial indicators, media fills, and utilities)
Support investigations when abnormal results are found.
Write reports to support qualification of new equipment and requalification.
Support continuous improvement activities and the transition to a Lean Manufacturing Environment.