Technician/Specialist I, Validation

Serán BioScience • Bend, OR

5d • Onsite

About The Position

The Validation Technician or Specialist I provides hands-on support for validation and qualification activities in a pharmaceutical manufacturing environment. This entry-level role assists with executing, documenting, and maintaining validation programs for equipment, utilities, facilities, computerized systems, and manufacturing processes. The position supports compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards, and is suited to individuals beginning a career in pharmaceutical manufacturing, quality, engineering, or validation.

Validation is a regulatory requirement and must conform to cGMPs and FDA requirements. As part of a cross-functional team, the role helps execute validation studies for processes, cleaning, computerized systems, and qualification of equipment and critical utilities that support clinical and commercial distribution of sterile and non-sterile pharmaceutical products.

Requirements

• High school diploma required.
• Minimum of 2 years of experience in a manufacturing, quality, engineering, or validation role.
• Ability to follow detailed procedures and work instructions.
• Basic understanding of mechanical and process equipment.
• Proficiency with Microsoft Word, Excel, and Outlook, and ability to learn QMS systems.
• Ability to accurately document test results and observations.
• Basic troubleshooting and problem-solving skills.
• Must be able to lift 25 pounds at times.
• Consistent and predictable in-person attendance.
• Applicants must be authorized to work for an employer in the U.S.; the employer cannot sponsor or take over sponsorship of an employment visa.

Nice To Haves

• Technical certification or degree.
• 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

• Learn to 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 in accordance with Good Documentation Practices (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.
• 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; no employee match or vesting period is required.
• Various health plans with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED