QA Engineer: Pharmaceutical Validation & Compliance

Medium; Bend (OR); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Over four weeks of paid time off annually

Employer contributions to retirement accounts

Various health plans

Basic life and long-term disability insurance

Employee Assistance Program

Job summary

A biotechnology firm in Bend, Oregon, is seeking a Quality Assurance Engineer to support the Commercial Manufacturing Facility. The successful candidate will be responsible for compliance activities, validation lifecycle support, and mentoring. The role requires a Bachelor’s degree and significant experience in the pharmaceutical industry, specifically in qualifications and validations. This position offers a strong benefits package including paid time off, retirement contributions, and health plans.

Qualifications

• Thorough understanding of regulations such as 21 CFR Parts 11, 210, 211.
• Experience in performing qualifications and validations.

Responsibilities

• Generate and support risk assessments and user requirements specifications.
• Support validation lifecycle activities and compliance decisions.
• Mentor colleagues on compliance requirements.
• Drive process improvement initiatives.
• Support audits conducted by clients and regulators.

Skills

Understanding of current regulations and guidelines

Technical writing skills

Hands-on experience with qualification activities

Ability to manage multiple projects

Strong time-management skills

Effective communication

Proficiency in Microsoft Office

Education

Bachelor’s degree in science, engineering, or related field

Minimum of 4 years experience in the pharmaceutical industry

Minimum of 4 years performing qualifications and/or validations

Job description

A biotechnology firm in Bend, Oregon, is seeking a Quality Assurance Engineer to support the Commercial Manufacturing Facility. The successful candidate will be responsible for compliance activities, validation lifecycle support, and mentoring. The role requires a Bachelor’s degree and significant experience in the pharmaceutical industry, specifically in qualifications and validations. This position offers a strong benefits package including paid time off, retirement contributions, and health plans.