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Senior GMP Microbiology Laboratory Consultant
Job Location:
Job Location:
Mundelein, IL - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
5 September 2026 (26 days ago)
Posted:
Application Deadline:
9 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Senior GMP Microbiology Laboratory Consultant
VTI Life Sciences is seeking an experienced Senior Microbiologist to support an assessment of an in-house microbiology laboratory supporting product release and environmental monitoring activities for multiple manufacturing sites. The consultant will evaluate laboratory operations procedures test methods documentation facilities equipment and quality systems for compliance with applicable current Good Manufacturing Practice (cGMP) requirements USP requirements and recognized pharmaceutical microbiology industry practices.
The successful candidate should have extensive hands-on and/or laboratory leadership experience in a GMP-regulated pharmaceutical microbiology laboratory and be able to independently identify compliance gaps evaluate microbiological practices from both a regulatory and scientific perspective and recommend practical corrective and improvement actions.
We offer an opportunity to support our teams of industry subject-matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.
PROJECT OVERVIEW
Education
The ideal candidate is a senior pharmaceutical microbiologist who has previously managed audited or served as an SME for a GMP Quality Control microbiology laboratory. The individual should have substantial hands-on familiarity with product-release microbiology and environmental monitoring and understand how these activities are expected to operate within a mature pharmaceutical quality system.
The strongest candidate will have participated in FDA or other regulatory inspections conducted internal or supplier laboratory audits investigated significant microbiological excursions or contamination events and helped remediate laboratory compliance deficiencies.
For this assignment we are particularly interested in someone who can go beyond checking SOPs against regulations. The consultant should be able to observe actual laboratory practices interview analysts and management review representative data and investigations and determine whether the laboratory is operating in a state of control and whether its microbiological results are scientifically sound reliable and suitable for supporting product-release and environmental-monitoring decisions.
VTI Life Sciencesstrives to maintain and inspire professional excellence by providing Commissioning Qualification Quality Engineering Automation and Validation Services to the Pharmaceutical Biotechnology Biologics and Medical Device professional development training competitive compensation excellent benefits a matching 401K and a stimulating collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust respect openness teamwork creative talent enthusiasm and diligence.
VTI Life Sciences is seeking an experienced Senior Microbiologist to support an assessment of an in-house microbiology laboratory supporting product release and environmental monitoring activities for multiple manufacturing sites. The consultant will evaluate laboratory operations procedures test methods documentation facilities equipment and quality systems for compliance with applicable current Good Manufacturing Practice (cGMP) requirements USP requirements and recognized pharmaceutical microbiology industry practices.
The successful candidate should have extensive hands-on and/or laboratory leadership experience in a GMP-regulated pharmaceutical microbiology laboratory and be able to independently identify compliance gaps evaluate microbiological practices from both a regulatory and scientific perspective and recommend practical corrective and improvement actions.
We offer an opportunity to support our teams of industry subject-matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.
PROJECT OVERVIEW
- Location: Mundelein IL
- Start Date: September 2026
- Employment Classification: Contract
- Length of Project: Approximately 4-6months
- 90% to 100% On-site.
- Conduct a comprehensive assessment of microbiology laboratory operations against applicable FDA cGMP requirements USP requirements internal procedures and recognized industry practices.
- Evaluate laboratory organization staffing training analyst qualification supervision and quality oversight.
- Review microbiological testing associated with product release raw materials utilities environmental monitoring and other applicable laboratory programs.
- Assess laboratory practices for microbial enumeration specified microorganism testing bioburden testing microbial identification and other microbiological methods applicable to the products tested by the laboratory.
- Assess laboratory controls for media preparation growth-promotion testing media storage culture maintenance reference organisms reagents and microbiological supplies.
- Review microbiological method suitability verification validation and method transfer practices as applicable.
- Evaluate laboratory equipment qualification calibration preventive maintenance and routine controls for equipment such as incubators autoclaves refrigerators/freezers biological safety cabinets air samplers colony counters and other microbiology laboratory equipment.
- Assess sample receipt handling storage chain of custody testing retention and disposition practices.
- Review laboratory data integrity and documentation practices including raw data worksheets electronic systems audit trails where applicable calculations second-person review and Good Documentation Practices.
- Evaluate procedures for handling atypical results excursions deviations OOS/OOT results environmental monitoring excursions microbial identifications investigations CAPA and associated trend analysis.
- Assess laboratory controls intended to prevent contamination and cross-contamination during microbiological testing.
- Evaluate laboratory facility design and workflow including segregation of activities personnel/material flow sample handling media preparation incubation organism handling and waste management.
- Review the adequacy of SOPs specifications test methods protocols records and other controlled laboratory documentation.
- Identify compliance gaps operational weaknesses and opportunities for improvement; classify or prioritize findings based on potential product quality patient and regulatory risk.
- Develop clear practical recommendations for remediation and laboratory improvement.
- Prepare and/or contribute to an assessment report summarizing observations compliance gaps risks and recommended corrective actions.
- Discuss findings with laboratory management Quality manufacturing-site representatives and other stakeholders.
Education
- Bachelors degree or higher in Microbiology Biology Biological Sciences or a related scientific discipline.
- Advanced degree in Microbiology or a related discipline is preferred but not required.
- Minimum of 10 years of pharmaceutical biotechnology or similarly regulated microbiology laboratory experience preferably including significant experience in a GMP Quality Control microbiology laboratory.
- Strong experience with microbiological testing supporting pharmaceutical product release and/or manufacturing operations.
- Experience with laboratory investigations involving microbial excursions OOS/OOT results contamination events and microbial identification.
- Experience assessing or auditing GMP microbiology laboratories strongly preferred.
- Previous laboratory supervisory management technical-lead or SME experience preferred.
- Experience supporting FDA inspections regulatory inspections internal audits or remediation activities is highly desirable.
- FDA 21 CFR Parts 210 and 211 particularly laboratory control requirements under 21 CFR 211 Subpart I.
- USP General Chapters applicable to pharmaceutical microbiology including USP <61> <62> <1111> and <1115> as applicable to the products and testing performed.
- USP <1116> where environmental monitoring principles are applicable.
- Applicable USP requirements for microbiological test methods media growth promotion and method suitability.
- FDA expectations for investigating OOS laboratory results.
- Data integrity principles including ALCOA.
- Good Documentation Practices (GDP).
- Microbiological method validation verification suitability and transfer principles.
- Environmental monitoring program design execution investigation and trending.
- Current industry practices for contamination control within microbiology laboratories.
- Strong technical knowledge of pharmaceutical microbiology and GMP laboratory operations.
- Ability to distinguish between true regulatory requirements and industry best practices when evaluating laboratory operations.
- Strong observational and interviewing skills and the ability to identify systemic issues rather than simply procedural deficiencies.
- Ability to evaluate microbiological practices from both a scientific and GMP compliance perspective.
- Strong understanding of microbiological contamination risks and investigation techniques.
- Excellent technical writing skills with the ability to clearly document observations risks and recommendations.
- Ability to communicate findings constructively with laboratory analysts management Quality personnel and senior leadership.
- Ability to independently assess complex laboratory operations and exercise sound professional judgment.
- Practical risk-based approach to remediation rather than simply identifying deficiencies.
The ideal candidate is a senior pharmaceutical microbiologist who has previously managed audited or served as an SME for a GMP Quality Control microbiology laboratory. The individual should have substantial hands-on familiarity with product-release microbiology and environmental monitoring and understand how these activities are expected to operate within a mature pharmaceutical quality system.
The strongest candidate will have participated in FDA or other regulatory inspections conducted internal or supplier laboratory audits investigated significant microbiological excursions or contamination events and helped remediate laboratory compliance deficiencies.
For this assignment we are particularly interested in someone who can go beyond checking SOPs against regulations. The consultant should be able to observe actual laboratory practices interview analysts and management review representative data and investigations and determine whether the laboratory is operating in a state of control and whether its microbiological results are scientifically sound reliable and suitable for supporting product-release and environmental-monitoring decisions.
VTI Life Sciencesstrives to maintain and inspire professional excellence by providing Commissioning Qualification Quality Engineering Automation and Validation Services to the Pharmaceutical Biotechnology Biologics and Medical Device professional development training competitive compensation excellent benefits a matching 401K and a stimulating collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust respect openness teamwork creative talent enthusiasm and diligence.
Required Experience:
Manager
About Company
VTI has successfully managed and executed hundreds of validation services projects for Pharmaceutical, Biotechnology and Medical Device manufacturers.
