About this role
Duties & Responsibilities
- Execute validation protocols under the guidance of Validation Engineers and Quality personnel.
- Perform data collection and testing activities during, Installation Qualification, Operational Qualification and Performance Qualification
- Assist with equipment startup, commissioning, and qualification activities.
- 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.
- 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
- 0-2 years experience in a manufacturing, quality, engineering, or validation setting.
- Internship, co-op, vocational training, or GMP experience preferred but not required.
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 fifteen pounds at times.
- Adheres to consistent and predictable in-person attendance