Microbiology Validation
Job in
East Troy, Walworth County, Wisconsin, 53120, USA
Listed on 2026-08-12
Listing for:
Actalent
Full Time
position Listed on 2026-08-12
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
Job Description & How to Apply Below
Job Title:
Microbiology Validation Engineer
The Microbiology Validation Engineer is responsible for planning, executing, and delivering microbiological method validation and laboratory validation activities in support of a cGMP remediation and validation program. This role ensures that analytical methods are scientifically sound, appropriately validated, and compliant with current regulatory expectations and pharmaceutical laboratory cGMP requirements.
Responsibilities
+ Lead the validation of rapid microbiological methods, including the Neo Gen system, to ensure reliability and regulatory compliance.
+ Perform method suitability testing across multiple product matrices to confirm that methods are appropriate for their intended use.
+ Design and execute comparative studies against compendial United States Pharmacopeia (USP) methods to demonstrate equivalency or superiority of new methods.
+ Develop and execute dilution validation studies and related experimental designs to support robust microbiological testing strategies.
+ Independently author validation protocols, reports, and supporting documentation for microbiological and laboratory validation activities.
+ Prepare risk assessments related to microbiological methods and laboratory processes, and propose appropriate mitigation strategies.
+ Lead and document deviation investigations associated with microbiological testing and validation activities, ensuring thorough root cause analysis and corrective actions.
+ Apply working knowledge of 21 CFR Parts 210 and 211, data integrity principles, and pharmaceutical laboratory cGMP requirements to all validation activities.
+ Collaborate closely with Operations, Quality, and Leadership teams to align validation activities with business needs and regulatory expectations.
+ Explain regulatory and validation requirements in practical, business-focused terms to non-quality personnel to support understanding and adoption.
+ Influence stakeholders without direct authority to build consensus around new procedures, documentation requirements, and quality system improvements.
+ Support implementation of new and improved quality systems and processes in environments with low process maturity or developing quality systems.
+ Balance compliance objectives with operational realities while maintaining adherence to regulatory expectations and quality standards.
Essential Skills
+ Demonstrated experience developing and executing microbiological method validations in a cGMP-regulated pharmaceutical or biotechnology environment.
+
Experience with rapid microbial methods, method suitability studies, and comparative testing against compendial USP methods.
+ Proven ability to independently author validation protocols, validation reports, risk assessments, and deviation investigations.
+ Strong experience in microbiological method validation and associated validation testing activities.
+ Strong experience with USP and other compendial methods used in pharmaceutical microbiology.
+
Experience with rapid microbiological systems, with specific exposure to platforms such as the Neo Gen system preferred.
+ Working knowledge of 21 CFR Parts 210 and 211, data integrity principles, and pharmaceutical laboratory cGMP requirements.
+ 3-7+ years of experience in pharmaceutical or biotech validation roles.
+ Bachelor's degree in Microbiology, Biology, Chemistry, or a closely related scientific field.
Additional
Skills & Qualifications
+ Experience working in organizations with low process maturity or developing quality systems, and contributing to the evolution of those systems.
+ Ability to clearly explain regulatory and validation requirements in practical, business-focused language to non-quality stakeholders.
+ Comfort influencing stakeholders without direct authority and building consensus across Operations, Quality, and Leadership teams.
+ Patient, adaptable approach to implementing change in environments that may be resistant to new procedures and documentation requirements.
+ Ability to balance compliance objectives with operational realities while maintaining regulatory expectations and quality standards.
+
Experience with validation concepts and activities such as installation qualification (IQ), operational qualification (OQ), process validation, and validation testing.
+ Strong written and verbal communication skills to produce clear documentation and to collaborate effectively with cross-functional teams.
+ Demonstrated problem-solving skills and the ability to perform thorough root cause analysis in deviation investigations.
+ High attention to detail and commitment to maintaining data integrity in all laboratory and validation activities.
Work Environment
This role is based onsite in a cGMP-regulated pharmaceutical or biotechnology laboratory environment. The Microbiology Validation Engineer works closely with Operations, Quality, and Leadership teams, engaging in hands-on microbiological testing, method validation, and laboratory validation activities. The…
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