Scientist - Microbiology

Job Title:

Scientist - Microbiology

Job Description

This role supports a Quality Control (QC) team in a GMP-regulated pharmaceutical environment, with a primary focus on validation and qualification of microbiological methods. The scientist ensures that microbiological testing methods are compliant, robust, and aligned with regulatory expectations while contributing to continuous improvement of quality systems, validation practices, and laboratory operations. This position is ideal for a microbiology professional who wants to deepen their experience in QC method validation and advance their career in a biomanufacturing setting.

Responsibilities

+ Lead and support the validation and qualification of microbiological methods to ensure compliance with GMP and regulatory requirements.

+ Assist with the development, execution, and documentation of method validation protocols, including IQ, OQ, and PQ activities.

+ Perform and support routine and non-routine microbiological testing such as bioburden, endotoxin, sterility, and related assays.

+ Record, analyze, and document validation and testing results in accordance with quality standards and data integrity expectations.

+ Collaborate closely with cross-functional teams, including Quality Control, Quality Assurance, and operations, to plan and execute validation activities.

+ Support QC method validation or method transfer activities to ensure smooth implementation and consistency across laboratories.

+ Utilize electronic systems and documentation tools, such as LIMS, to manage data, track samples, and maintain accurate records.

+ Contribute to the continuous improvement of microbiology methods, laboratory processes, and quality systems by identifying opportunities and proposing enhancements.

+ Maintain adherence to GMP, regulatory guidelines, and internal procedures during all laboratory and documentation activities.

+ Support training and knowledge sharing within the QC team related to microbiological methods and validation practices.

Essential Skills

+ Bachelor's degree in Microbiology, Biology, or a related scientific field.

+ 2-5+ years of experience working in a GMP-regulated microbiology laboratory.

+ At least 2 years of hands-on experience with endotoxin and bioburden methods.

+ Strong understanding of GMP principles and regulatory compliance requirements for pharmaceutical microbiology.

+ Experience supporting QC method validation or method transfer activities.

+ Demonstrated knowledge of method qualification and validation concepts, including IQ, OQ, and PQ.

+ Proficiency in performing microbiological assays such as bioburden, endotoxin, and sterility testing.

+ Ability to accurately document laboratory activities and results in alignment with data integrity and quality standards.

+ Experience using electronic systems and documentation platforms, such as LIMS, for sample and data management.

+ Strong attention to detail, organizational skills, and ability to follow written procedures and protocols.

Additional

Skills & Qualifications

+ Experience working within a pharmaceutical biomanufacturing facility.

+ Prior involvement in quality systems and continuous improvement initiatives within a QC laboratory.

+ Familiarity with cross-functional collaboration between QC, QA, and operations teams.

+ Interest in expanding expertise in method validation and qualification to support career growth.

+ Ability to adapt to evolving laboratory processes and contribute ideas for process optimization.

+ Strong communication skills to effectively share findings and collaborate across teams.

+ Motivation to work on a longer-term project engagement with opportunities for professional development.

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Experience with electronic data integrity practices and compliance expectations in a regulated environment.

Work Environment

The role is based in a pharmaceutical biomanufacturing facility within a quality control testing laboratory. Approximately 80% of the time is spent in the lab performing microbiological testing on samples, with the remaining time spent in an office area located down the hallway due to ongoing lab renovations. The environment is GMP-regulated and focused on high-quality,…