Validation Technician

Serán BioScience • Bend, OR

6d • Onsite

About The Position

The Validation Technician I provides hands-on support for validation and qualification activities in a pharmaceutical manufacturing environment. The role assists with executing, documenting, and maintaining validation programs for equipment, utilities, facilities, computerized systems, and manufacturing processes. It supports compliance with cGMP, regulatory requirements, and company quality standards.

The technician is part of a cross-functional team conducting validation studies for processes, cleaning, computerized systems, and qualification of equipment and critical utilities used to support clinical and commercial distribution of sterile and non-sterile pharmaceutical products. This entry-level role is intended for individuals beginning a career in pharmaceutical manufacturing, quality, engineering, or validation.

Requirements

• 0–2 years of experience in a manufacturing, quality, engineering, or validation setting.
• 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.
• Authorization to work for an employer in the United States; the employer cannot sponsor or take over sponsorship of an employment visa.

Nice To Haves

• Internship, co-op, vocational training, or GMP experience.
• Knowledge of Good Manufacturing Practices (cGMP).
• Knowledge of Good Documentation Practices (GDP).
• Knowledge of pharmaceutical or biotechnology manufacturing operations.
• Knowledge of equipment calibration and maintenance concepts.
• Knowledge of validation and qualification processes.

Responsibilities

• Execute validation protocols under the guidance of Validation Engineers and Quality personnel.
• Perform data collection and testing 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.
• 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.
• Coordinate validation activities with Manufacturing, Engineering, Maintenance, Laboratory, and Quality teams.
• Ensure activities comply with safety procedures, cGMP requirements, and company policies.
• Support regulatory inspections and internal audits by retrieving and organizing validation documentation.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer contributions to a retirement account begin after 90 days; employee matching and a vesting period are not required.
• Multiple health plan options with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program support for employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed