Associate Scientist

Overview

Perform microbiology testing, validation support, and GMP documentation in pharma lab.

Key Responsibilities

• sop development
• instrument troubleshooting
• environmental monitoring
• lims entry
• microbial identification
• assay execution

Tasks

-Develop and execute protocols and Standard Operating Procedures for microbiology equipment, assays, and test methods. -Troubleshoot instruments when necessary and utilize classical microbiological methods for microorganism identification. -Perform sample shipments to contract testing laboratories. -Monitor facilities for non-viable particulates and viable air and surface using calibrated and validated equipment. -Enter data for finished products and raw materials into the Laboratory Information Management System. -Identify bacteria and fungi using microscopy and phenotypic/genotypic methods. -Support validation by conducting bioburden swab testing, biological indicator testing, and endotoxin challenge vial testing. -Document test results and conclusions in a GMP manner and ensure test forms are complete before submission for approval. -Support the Environmental Monitoring Program by testing clean steam, USP water, Water for Injection, nitrogen, and process air for microbial and particulate content. -Review data generated by laboratory personnel and provide guidance and training on instrument operation and test methods. -Conduct microbiological assays and testing using methods such as Turbidimetric/Chromogenic/Gel Clot for bacterial endotoxins, Microbial Limits Test/Bioburden determination, and Sterility Test.

Requirements

• gmp
• lims
• usp61
• usp85
• microbiology
• technical writing

What You Bring

-GMP documentation experience. -Experience in Chemistry, Biology, Laboratory, Biochemistry, Analytic Assays. -Experience in supporting testing and monitoring for microbial and particulate content. -Ability to execute validation protocols for bioburden swabs, biological indicators, and endotoxin challenge vials. -Experience in lab testing, particularly in the pharmaceutical industry. -Experience with LIMS/MIMS for tracking and entering data. -Proficiency in USP 61 and 85 testing. -At least one year of professional experience outside of college labs. -Strong skills in technical writing and microbiology.

People Also Searched For

Benefits

-401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Time Off/Leave (PTO, Vacation or Sick Leave) -Medical, dental & vision -Critical Illness, Accident, and Hospital -Transportation benefits -Short and long-term disability -Health Spending Account (HSA) -Life Insurance (Voluntary Life & AD&D for the employee and dependents)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms