Validation Technician

Job Title

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation personnel are involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The Validation Technician, under the direct supervision of the Validation Engineer, validates and maintains validation records of pharmaceutical and biotech product manufacturing equipment and processes by performing the following duties:

• Conduct temperature mapping studies, including the operation of Kaye dataloggers, or equivalent.
• Review and approve documented test results and maintain records for later analysis.
• Assist with non-conformances, investigations, and troubleshooting of equipment, utilities, and systems.
• Works closely with client site manufacturing, engineering, and QA personnel to develop validation documents.
• Provide qualification and validation services for cGMP manufacturing equipment, systems, and utilities at client sites.
• Exposure to validation aspects of facility start-up, redesign/retrofit, and expansion.
• Travel to various client sites and work independently to complete tasks.

Skill Level and Requirements:

• Good written and oral communications skills, including technical writing
• Good problem-solving and trouble-shooting skills
• Good interpersonal and organizational skills
• Computer skills including Microsoft Word and Microsoft Excel
• Experience with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired
• Experience using statistical tools is a plus to analyze data captured during validation studies

Minimum Requirements:

• High school diploma with additional technical courses in Scientific, Engineering or Quality fields preferred
• 0-2 years of experience in at least one of the following areas: temperature mapping, analyzing data, general validation knowledge.
• Current driver's license and auto insurance

Quality Agents offers a full suite of benefits for full-time employees including:

• Health, dental and vision insurance
• Life, AD&D and disability insurance
• Health savings account for participants in our health plan
• 401k retirement plan
• Paid vacation
• Paid sick leave

Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.