Record validation results accurately and in accordance with Good Documentation Practices (GDP)
Collect and organize calibration, maintenance, and testing records required for validation packages
Review completed validation documentation for accuracy and completeness
Support environmental, utility, and process monitoring activities as required
Assist in identifying and documenting validation deviations and discrepancies
Maintain validation logs, binders, and electronic records
Work closely with Manufacturing, Engineering, Maintenance, Laboratory, and Quality teams to coordinate validation activities
Ensure all activities comply with safety procedures, cGMP requirements, and company policies
- Support regulatory inspections and internal audits by retrieving and organizing validation documentation
- Required Skills & Abilities
- Technical Skills
Ability to follow detailed procedures and work instructions
Basic understanding of mechanical and process equipment
Proficiency with Microsoft Word, Excel, and Outlook with the ability to learn QMS systems
Ability to accurately document test results and observations
Basic troubleshooting and problem-solving skills
Preferred Knowledge
Good Manufacturing Practices (cGMP)
Good Documentation Practices (GDP)
Pharmaceutical or biotechnology manufacturing operations
Equipment calibration and maintenance concepts
- Validation and qualification processes
- Education & Experience
- High School Diploma required, technical certification or degree prefered
Minimum of 2 years of experience in a manufacturing, quality, engineering, or validation role
- Internship, co-op, vocational training, or GMP experience preferred
- Physical Requirements
- Prolonged periods of sitting or standing at a desk and working on a computer
Prolonged periods of sitting or standing in a manufacturing environment
Must be able to lift 25 pounds at times
Adheres to consistent and predictable in-person attendance
