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 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.
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 NeoGen 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 environment emphasizes adherence to cGMP, data integrity, and regulatory compliance, with a strong focus on continuous improvement of quality systems and processes.
Job Type & Location
This is a Permanent position based out of East Troy, WI.
Pay and Benefits
The pay range for this position is $60.00 - $65.00/hr.
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 & vision • Critical Illness, Accident, and Hospital • 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)
Workplace Type
This is a fully onsite position in East Troy,WI.
Application Deadline
This position is anticipated to close on Aug 18, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
