Job Title: Environmental Monitoring Trending Analyst Job Description The Environmental Monitoring (EM) Trending Analyst is responsible for collecting, analyzing, and trending microbiological and particulate data from cleanroom environments to ensure compliance with cGMP regulations and internal quality standards. This role supports contamination control strategies and contributes to maintaining a state of control in aseptic manufacturing areas. Responsibilities • Collect, compile, and trend viable and non-viable environmental monitoring data (air, surface, personnel). • Generate periodic EM trend reports (monthly, quarterly, annual) and present findings to QA and manufacturing leadership. • Investigate EM excursions and support root cause analysis and CAPA implementation. • Maintain and improve EM databases and data visualization tools (e.g., Excel, LIMS, MODA, etc.). • Collaborate with QA, manufacturing, and validation teams to support cleanroom qualification and contamination control initiatives. • Ensure compliance with regulatory requirements (FDA, EMA, MHRA) and internal SOPs. • Participate in audits and inspections, providing EM data and documentation as needed. Essential Skills • 3+ years of experience in pharmaceutical environmental monitoring. • Strong understanding of aseptic processing, cleanroom classifications, and cGMP regulations. • Proficiency in data analysis tools (Excel, statistical software, LIMS, MODA). • Excellent attention to detail, organizational, and communication skills. Additional Skills & Qualifications • Bachelor’s degree in Microbiology, Biology, or a related scientific field preferred. • Experience with contamination control and CAPA. Work Environment The work environment involves working in cleanroom settings with a focus on maintaining a state of control in aseptic manufacturing areas. The role requires collaboration with various teams including QA, manufacturing, and validation. Dress code is likely to adhere to cleanroom standards, ensuring compliance with safety and hygiene protocols. Pay and Benefits The pay range for this position is $30.00 - $40.00/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 Raleigh,NC. Application Deadline This position is anticipated to close on Jul 17, 2025. 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.