Validation Technician

Serán BioScience; Bend (OR); On-site; USD 42,000 - 66,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life & disability

Employee Assistance Program

Pet insurance

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Detailed procedures

Mechanical understanding

MS Word/Excel/Outlook

Documentation/testing

Troubleshooting basics

Job description

Validation is a regulatory requirement and must be conducted in conformance to cGMPs and FDA requirements. The Validation Technician will be part of a cross functional team that will execute validation studies for process, cleaning, computerized systems, and qualification of equipment and critical utilities needed to support clinical and commercial distribution of sterile and non-sterile pharmaceutical products.

The Validation Technician I provides hands‑on support for validation and qualification activities within a pharmaceutical manufacturing environment. This entry‑level role assists with the execution, documentation, and maintenance of validation programs for equipment, utilities, facilities, computerized systems, and manufacturing processes. The position plays a critical role in ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards.

This role is ideal for individuals beginning a career in pharmaceutical manufacturing, quality, engineering, or validation.

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

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary

• Serán employees accrue over four weeks of paid time off annually.
• Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
• Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions.
• Serán covers each employee with basic life and long‑term disability, giving access to increase or add coverage.
• An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701