Micro Contamination Investigator - Remote

Job description

Location: Remote after initial onsite training in Minnesota or Wisconsin

Travel: Travel expenses paid

Position Overview

We are seeking experienced Micro Contamination Investigators to support contamination investigations and remediation activities within a regulated pharmaceutical manufacturing environment.

This position requires travel to Minnesota or Wisconsin for an initial kickoff and approximately one to two weeks of onsite training. After training is completed, the position will be 100% remote. Approved travel expenses will be covered.

Key Responsibilities

Lead investigations involving microbial contamination events and environmental-monitoring excursions.

Perform root-cause analysis using methods such as 5 Whys and Fishbone/Ishikawa analysis.

Develop and implement corrective and preventive actions (CAPAs).

Write contamination assessments, deviation investigations, risk assessments, and technical reports.

Audit completed batch records to identify contamination risks and process deviations.

Review environmental-monitoring data and microbiological sampling records.

Provide technical guidance regarding cleanrooms, aseptic processing, disinfection practices, and contamination prevention.

Evaluate manufacturing equipment and utility systems, including WFI and HVAC systems, for potential bioburden risks.

Support the development and revision of the site’s Contamination Control Strategy.

Train manufacturing personnel on aseptic techniques, cleanroom behavior, and contamination-control practices.

Ensure investigations and documentation meet applicable regulatory and internal quality requirements.

Required Qualifications

At least five years of experience in a microbiology manufacturing environment.

Direct experience in pharmaceutical, biologic, biotechnology, or medical-device manufacturing.

Hands-on experience investigating contamination events, microbial excursions, or environmental-monitoring excursions.

Strong knowledge of aseptic processing, environmental monitoring, microbiological sampling, and cleanroom classifications.

Experience writing deviations, CAPAs, investigation reports, and risk assessments.

Proficiency with root-cause analysis methodologies.

Strong technical-writing, analytical, and problem-solving abilities.

Ability to work independently and manage investigations through completion.

Willingness and ability to travel to Minnesota or Wisconsin for kickoff and onsite training.

Preferred Qualifications

Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related scientific discipline.

Knowledge of FDA, EMA, cGMP, and EU Annex 1 requirements.

Experience supporting or developing a Contamination Control Strategy.

Experience evaluating WFI, HVAC, equipment, and facility-related microbial risks.

Familiarity with statistical data-analysis tools.

Work Arrangement

The selected consultant must attend the initial kickoff and complete approximately one to two weeks of onsite training in Minnesota or Wisconsin. Following training, the assignment will be fully remote. Travel expenses will be paid.

Qualified candidates with pharmaceutical microbiology, contamination-investigation, environmental-monitoring, CAPA, and aseptic-processing experience are encouraged to apply.

Arthur Lawrence is a US-focused management consulting and staffing firm placing talent across IT, finance, light industries, and pharmaceuticals. We work with Fortune 500 clients and operate with a delivery-first mindset backed by a strong internal training culture.