Pharma Validation Technician I - Quality and Compliance

Serán BioScience; Bend (OR); Vor Ort; USD 42.000 - 66.000; Vollzeit

Benefits dieser Stelle

Paid time off

Retirement plan

Health plans

Life & disability

Employee Assistance Program

Pet insurance

Zusammenfassung

Serán BioScience in Bend, Oregon seeks an entry-level Validation Technician I to support validation and qualification activities for equipment, processes, and systems in a cGMP environment. You will work with cross-functional teams and help ensure regulatory compliance and accurate documentation, contributing to the safe, compliant production of clinical and commercial products.

This role offers hands-on learning, exposure to IQ/OQ/PQ, GDP, and collaboration with Manufacturing, Engineering, and

Qualifikationen

• 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.

Aufgaben

• Execute validation protocols under the guidance of Validation Engineers and Quality personnel.
• Perform data collection and testing activities during IQ/OQ/PQ phases.
• Assist with equipment startup, commissioning, and qualification activities.
• Record validation results accurately and in line with GDP.
• Collect and organize calibration, maintenance, and testing records 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.

Kenntnisse

Detailed procedures

Mechanical understanding

MS Word/Excel/Outlook

Documentation/testing

Troubleshooting basics

Jobbeschreibung

Serán BioScience in Bend, Oregon seeks an entry-level Validation Technician I to support validation and qualification activities for equipment, processes, and systems in a cGMP environment. You will work with cross-functional teams and help ensure regulatory compliance and accurate documentation, contributing to the safe, compliant production of clinical and commercial products.

This role offers hands-on learning, exposure to IQ/OQ/PQ, GDP, and collaboration with Manufacturing, Engineering, and