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Microbiology Validation Engineer @ Actalent

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About this role

Job Title: Microbiology Validation EngineerJob DescriptionJoin our team as a Microbiology Validation Engineer, where you will play a crucial role in executing and delivering microbiological method validation and laboratory validation activities. This role is integral to a cGMP remediation and validation program, ensuring that our analytical methods are scientifically sound, validated, and compliant with regulatory expectations. Responsibilities • Lead the validation of rapid microbiological methods utilizing the NeoGen system. • Perform method suitability testing across various product matrices. • Design and execute comparative studies against compendial (USP) methods. • Develop and validate dilution methods. Essential Skills • Demonstrated experience in developing and executing microbiological method validations within a CGMP-regulated environment. • Experience with rapid microbial methods, method suitability studies, and compendial testing comparisons. • Proven ability to independently author validation protocols, reports, risk assessments, and deviation investigations. • Working knowledge of 21 CFR Part 210/211, Data Integrity principles, and pharmaceutical laboratory CGMP requirements. Additional Skills & Qualifications • Bachelor’s Degree in Microbiology, Biology, Chemistry, or a related field. • 3–7+ years of experience in pharmaceutical or biotech validation. • Strong experience in microbiological method validation, USP/compendial methods, and rapid microbiological systems (preferred). • Ability to work effectively in organizations with low process maturity or developing quality systems. • Capability to explain regulatory and validation requirements to non-quality personnel in practical terms. • Comfortable influencing stakeholders 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. Work EnvironmentThe position is onsite, providing an opportunity to work directly with cutting-edge technologies and methodologies in a collaborative and dynamic setting. Job Type & LocationThis is a Contract position based out of East Troy, WI. Pay and BenefitsThe pay range for this position is $60.00 - $65.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.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 TypeThis is a fully onsite position in East Troy,WI. Application DeadlineThis position is anticipated to close on Sep 10, 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.

Skills

microbiology method validationusp/compendial testing21 cfr part 210/211rapid microbiological systemsmethod suitability testingdilution method developmentvalidation protocol writingrisk assessmentdeviation investigationpharmaceutical laboratory cgmpdata integrity principlescomparative studiesstakeholder managementconsensus buildingchange management

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