Overview
We are seeking a highly motivated Principal Microbiologist to join our team at a leading pharmaceutical company. This role is critical in ensuring contamination control, compliance with quality standards, and continuous improvement of microbiological processes. The successful candidate will provide technical expertise, collaborate with cross-functional teams, and drive excellence in microbiological quality control.
Job Description
As a Principal Microbiologist, you will be responsible for implementing and maintaining contamination control strategies while supporting aseptic processing and microbiological quality assurance. You will play a key role in troubleshooting contamination events, optimizing microbiological methods, and ensuring compliance with regulatory requirements.
Key Responsibilities
* Implement and maintain the Contamination Control Strategy and associated risk assessments.
* Provide on-the-floor support and act as a Subject Matter Expert for bio-decontamination prevention and control.
* Identify and lead process improvements in microbiological methods and contamination control.
* Support training on cleanroom behaviors and aseptic processing.
* Troubleshoot contamination events, including Bioburden, Sterility, Environmental Monitoring, and Utilities.
* Manage Change Controls, Investigations, Deviations, and Quality Risk Management processes.
* Support regulatory audits and ensure compliance with GxP and safety standards.
* Collaborate with Operations, Quality Assurance, Validation, and Facilities teams to enhance microbiological processes.
* Provide technical expertise to Quality Control (QC) and external teams.
* Review and approve standard operating procedures (SOPs), protocols, reports, and nonconformance documents.
* Plan and execute projects related to microbiological methods and technologies.
* Ensure timelines are effectively managed and deliverables are met.
* Lead and mentor team members to foster professional growth and enhance technical capabilities.
* Conduct and document out-of-specification and out-of-trend result investigations.
* Drive initiatives that add value to QC and site operations.
Qualifications
* Bachelor’s or Master’s degree in Microbiology, Biology, or a related field.
* 8+ years of experience in microbiology within a pharmaceutical or regulated environment.
* Strong knowledge of contamination control, aseptic processing, and microbiological testing methods.
* Experience in Change Controls, Investigations, Deviations, and Quality Risk Management.
* Familiarity with GxP regulations and industry standards.
* Excellent communication and technical writing skills.
* Ability to work collaboratively across departments and manage multiple projects effectively.
Who You Are
* A detail-oriented professional with a passion for microbiology and quality assurance.
* A proactive problem solver with strong analytical and investigative skills.
* A team player who thrives in a fast-paced, regulated environment.
Where You Come From
You have a strong background in microbiology and contamination control within a regulated pharmaceutical setting. Your technical expertise, problem-solving skills, and commitment to continuous improvement make you an asset to any quality-focused organization.
What We Offer
* Competitive salary.
* Opportunities for professional development and career progression.
* A collaborative and dynamic work environment.
* The opportunity to make a meaningful impact on pharmaceutical quality and patient safety
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