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Validation Intern

2 weeks ago

Rockville, MD, United States Quality Agents Full time

Company Overview:

Quality Agents, LLC provides expert validation and quality assurance services to the pharmaceutical and biotechnology industries. Our team ensures that equipment, systems, and processes used in the development and production of drug products meet current Good Manufacturing Practices (cGMP) and regulatory standards.

Position Summary:

We are seeking a motivated Validation Intern to support our validation team in delivering high-quality services to clients in the pharmaceutical and biotech industries. This internship offers hands-on experience with equipment qualification, system validation, and documentation preparation in regulated manufacturing environments. Interns will work under the guidance of experienced validation professionals and gain exposure to real-world validation projects.

Key Responsibilities:

  • Assist in preparing validation documents, including protocols, reports, and data summaries.
  • Support the execution of equipment and utility qualification activities at client sites.
  • Observe and help conduct temperature mapping studies using validation tools (e.g., data loggers).
  • Learn to interpret engineering drawings (P&IDs, isometric and As-built diagrams).
  • Help review and organize validation data and test results.
  • Participate in troubleshooting and investigation activities under supervision.
  • Collaborate with internal teams and client personnel to support project timelines and deliverables.
Learning Opportunities:
  • Exposure to cGMP environments and regulatory expectations (FDA, EMA, ICH).
  • Understanding of validation approaches for pharmaceutical equipment, facilities, and systems.
  • Introduction to validation tools and instrumentation, including Kaye Validators and wireless data loggers.
  • Hands-on training in technical writing and documentation practices in a regulated setting.
Preferred Qualifications:
  • Currently pursuing a degree in Engineering, Life Sciences, Chemistry, or a related technical field.
  • Strong interest in pharmaceutical/biotech industries and quality systems.
  • Basic proficiency in Microsoft Word, Excel, PowerPoint.
  • Strong written and verbal communication skills.
  • Ability to work independently and as part of a team.
  • Detail-oriented with strong organizational skills.
Nice to Have:
  • Familiarity with validation or lab instrumentation (e.g., data loggers, sensors).
  • Exposure to technical documentation or laboratory notebook keeping.
  • Experience using basic statistical tools or Excel-based data analysis.

Location: Various Client Sites (Travel May Be Required)
Industry: Pharmaceutical & Biotechnology
Internship Type: Part-Time or Full-Time, Paid Internship
Duration: 2-6 Months