Microbiology Validation

About the role

This role ensures that analytical methods are scientifically sound, appropriately validated, and compliant with current regulatory expectations and pharmaceutical laboratory cGMP requirements in support of a cGMP remediation and validation program.

The Microbiology Validation Engineer works closely with Operations, Quality, and Leadership teams in a cGMP-regulated pharmaceutical or biotechnology laboratory environment, engaging in hands-on microbiological testing, method validation, and laboratory validation activities.

Responsibilities

• Lead the validation of rapid microbiological methods, including the NeoGen 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.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, or a closely related scientific field.
• 3–7+ years of experience in pharmaceutical or biotech validation roles.
• 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 with USP and other compendial methods used in pharmaceutical microbiology.
• Experience with rapid microbiological systems, with specific exposure to platforms such as the NeoGen system preferred.
• Working knowledge of 21 CFR Parts 210 and 211, data integrity principles, and pharmaceutical laboratory cGMP requirements.

Skills

• 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.

Pay

The pay range for this position is $60.00 - $65.00 per hour.

Benefits

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 following:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 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.