Microbiology Validation Engineer

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 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.

• 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.

• 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.

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.

Job Type & Location

This is a Contract position based out of East Troy, WI.

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)

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

This position is anticipated to close on Jul 20, 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 actalentaccommodation@actalentservices.com 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.