Associate Validation Engineer

Job Title: Associate Validation Engineer Location: North Carolina

Job Summary:

The Associate Validation Engineer will support validation and qualification efforts through documentation, data collection, and analytical assessments. This position primarily focuses on maintaining and preparing qualification documentation and assisting with data-driven validation processes. The role may also include thermocouple calibration, system updates, and related technical tasks, with an emphasis on maintaining compliance with cGMP standards.

Key Responsibilities:

Collect and review equipment documentation to identify and resolve gaps in records.

Work with Validation Engineers and QA Document Control to implement documentation improvements.

Support validation protocols through data collection and document creation as assigned.

Assist in the execution of equipment validation studies including protocol execution and data analysis.

Program and operate analytical instruments (e.g., temperature/humidity dataloggers) for chamber qualifications (e.g., lyophilizers, sterilizers, incubators).

Draft commissioning and qualification protocols to demonstrate process suitability.

Support system requalification and continuous improvement initiatives via change control processes.

Maintain compliance with regulatory guidelines and internal company procedures.

Skills & Competencies

• Strong understanding of documentation organization, preferably within a GMP-regulated environment.

• Excellent verbal and written communication skills.

• Strong attention to detail and problem-solving abilities.

• Proficient in Microsoft Office tools (Word, Excel, etc.).

• Basic mechanical skills are desirable.

• Preferred knowledge of statistical analysis tools and/or analytical methods.

• Education & Experience:

• Bachelor’s degree in Science, Engineering, Manufacturing Technology, or a closely related field, or equivalent relevant experience in a manufacturing setting.

• 3–5 years of experience in pharmaceutical manufacturing or validation.