Microbiology Validation Scientist
Job in
East Troy, Walworth County, Wisconsin, 53120, USA
Listed on 2026-08-05
Listing for:
Actalent
Full Time
position Listed on 2026-08-05
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Job Title:
Microbiology Validation Engineer
Job Description
The Microbiology Validation Engineer plays a key role in executing and delivering microbiological method validation and laboratory validation activities in support of a cGMP remediation and validation program. This position focuses on ensuring analytical methods are scientifically sound, appropriately validated, and fully compliant with current regulatory expectations in a pharmaceutical or biotechnology environment.
Responsibilities
+ Lead the validation of rapid microbiological methods, including implementation and optimization of the Neo Gen system.
+ 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 USP methods to demonstrate equivalency or superiority of rapid methods.
+ Develop and validate dilution schemes and related procedures to ensure accurate and reliable microbiological testing.
+ Independently author validation protocols, validation reports, and supporting documentation in accordance with cGMP and regulatory guidelines.
+ Prepare and perform risk assessments related to microbiological methods, laboratory processes, and validation activities.
+ Investigate and document deviations, identify root causes, and propose effective corrective and preventive actions.
+ Apply working knowledge of 21 CFR Parts 210 and 211, Data Integrity principles, and pharmaceutical laboratory cGMP requirements in daily work.
+ Collaborate closely with Operations, Quality, and Leadership teams to align validation activities with business and compliance objectives.
+ Explain regulatory and validation requirements in practical, business-focused terms to non-quality personnel to support understanding and adoption.
+ Influence stakeholders without direct authority and build consensus on validation strategies, procedures, and documentation requirements.
+ Support the development and improvement of quality systems in organizations with low process maturity or evolving quality frameworks.
+ Balance compliance objectives with operational realities while ensuring adherence to regulatory expectations.
+ Contribute to process validation efforts and related IQ/OQ activities where microbiological methods and laboratory systems are involved.
Essential Skills
+ Bachelor's degree in Microbiology, Biology, Chemistry, or a closely related scientific field.
+ 3-7+ years of experience in pharmaceutical or biotechnology validation roles.
+ Demonstrated experience developing and executing microbiological method validations in a cGMP-regulated environment.
+ Strong hands-on experience with microbiological method validation, including design, execution, and documentation.
+ Proficiency with USP and other compendial microbiological methods and their application in pharmaceutical testing.
+
Experience with rapid microbiological systems and rapid microbial methods, including validation and comparative testing.
+ Proven ability to independently author validation protocols, validation reports, risk assessments, and deviation investigations.
+ Working knowledge of 21 CFR Parts 210 and 211 and their application to pharmaceutical manufacturing and laboratory operations.
+ Solid understanding of Data Integrity principles and pharmaceutical laboratory cGMP requirements.
+
Experience with validation testing, process validation, and related IQ/OQ activities in a regulated environment.
Additional
Skills & Qualifications
+ Experience working in organizations with low process maturity or developing quality systems, with the ability to help build and refine processes.
+ Ability to explain complex regulatory and validation requirements in clear, practical, and business-oriented language to non-quality stakeholders.
+ Skill in influencing stakeholders without direct authority and building consensus across Operations, Quality, and Leadership teams.
+ Patient and adaptable approach to implementing change in environments that may be resistant to new procedures and documentation requirements.
+ Strong ability to balance compliance objectives with operational realities while maintaining regulatory expectations.
+ Excellent written and verbal communication skills for preparing documentation and collaborating with cross-functional teams.
+ Strong analytical and problem-solving skills for conducting risk assessments and investigating deviations.
+ High attention to detail and commitment to maintaining accurate, complete, and compliant documentation.
Work Environment
This is an onsite role in a cGMP-regulated pharmaceutical or biotechnology laboratory environment. The Microbiology Validation Engineer works closely with Operations, Quality, and Leadership teams in a setting focused on remediation, validation, and continuous improvement of analytical and microbiological methods. The work involves hands-on laboratory activities, interaction with rapid microbiological systems such as the Neo Gen system, and…
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