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 actively contributing to quality systems, validation activities, and laboratory operations. This position is ideal for a microbiology professional who wants to deepen expertise in QC method validation and advance their career in a biomanufacturing setting.

Responsibilities

+ Plan, execute, and support validation and qualification of microbiological methods in alignment with GMP and applicable regulatory requirements.

+ Assist with the development, review, and execution of method validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

+ Perform and support routine and non-routine microbiological testing, including bioburden, endotoxin, sterility, and related assays, in a Quality Control laboratory.

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

+ Use electronic systems, such as Laboratory Information Management Systems (LIMS), to manage test data, documentation, and method validation records.

+ Partner with cross-functional teams, including Quality Control (QC), Quality Assurance (QA), and operations, to coordinate and support method validation and transfer activities.

+ Contribute to continuous improvement initiatives for microbiology methods, laboratory workflows, and QC processes to enhance robustness, efficiency, and compliance.

+ Support QC method validation or transfer activities by providing microbiology expertise and ensuring methods are appropriately qualified for intended use.

+ Adhere to Good Manufacturing Practice (GMP) guidelines, laboratory procedures, and safety requirements while working in a pharmaceutical biomanufacturing facility.

Essential Skills

+ Bachelor's degree in Microbiology, Biology, or a closely 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, regulatory compliance requirements, and method qualification practices.

+ Practical experience performing microbiological testing such as bioburden, endotoxin, and sterility in a Quality Control environment.

+ Experience supporting QC method validation or method transfer activities.

+ Ability to develop, execute, and interpret method validation protocols, including IQ/OQ/PQ.

+ Strong documentation skills with a clear understanding of data integrity expectations in a regulated environment.

+ Ability to collaborate effectively with QC, QA, and operations teams to support validation and routine testing activities.

Additional

Skills & Qualifications

+ Experience using electronic systems and documentation tools, such as Laboratory Information Management Systems (LIMS).

+ Familiarity with validation lifecycle concepts and continuous improvement of laboratory methods and processes.

+ Demonstrated interest in quality systems, validation, and laboratory operations within a pharmaceutical or biomanufacturing setting.

+ Ability to work independently in a fast-paced QC laboratory while managing multiple validation and testing priorities.

+ Strong problem-solving skills and attention to detail when troubleshooting microbiological methods and test results.

Work Environment

The role is based in a Quality Control testing laboratory within a pharmaceutical biomanufacturing facility. 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 renovations in the lab. The environment is GMP-regulated and highly focused on compliance, data integrity, and safety.

Work is performed using standard microbiology laboratory equipment and electronic systems such as LIMS. The position follows a 4x10 schedule, with shifts available Sunday through Wednesday or Wednesday through Saturday, and candidate shift preference is taken into consideration. The workplace culture emphasizes professional growth, competitive compensation and benefits, and opportunities for QC professionals to gain substantial experience in method validation and advance their careers.

Job Type & Location

This is a Contract position based out of Sanford, NC.

Pay and Benefits

The pay range for this position is $30.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the…