Microbiology Validation Scientist

This role is a key contributor to executing and delivering microbiological method validation and laboratory validation activities in support of a cGMP remediation and validation program. The position ensures 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 NeoGen 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.

Requirements

• 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.

Skills

• 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 NeoGen system, and extensive use of validation and quality documentation. The environment supports collaboration, knowledge sharing, and the development of quality systems, with an expectation of professionalism and adherence to established laboratory and safety practices.

Pay

$60.00 - $65.00/hr

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a Contract, fully onsite position based in East Troy, WI.