QA Engineer for Pharma Validation & Compliance

Seranbio; Bend (OR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life and disability coverage

Employee Assistance Program

Job summary

Serán BioScience is expanding and seeking a Quality Assurance Engineer to join a cross-functional team responsible for qualification and validation of facilities, utilities, equipment, processes, cleaning, and computerized systems for the Commercial Manufacturing Facility.

You will generate risk assessments, URS, CQ plans, change controls, SOPs, CAPAs, and support audits while mentoring colleagues and driving process improvements to maintain validated state and regulatory compliance.

Qualifications

• Bachelor’s degree in science, engineering, or related field.
• Minimum 4 years in the pharmaceutical industry, with preference for 5–10 years of experience.
• Experience performing qualifications and/or validations.

Responsibilities

• Generate and/or support risk assessments, URS, C&Q plans, change controls, SOPs, CAPAs, and other relevant documents.
• Support validation lifecycle activities such as change management and periodic reviews to maintain validated state.
• Make compliance decisions to support commercial operations.
• Mentor colleagues on requirements and industry practices.
• Drive process improvement initiatives.
• Provide support during client and regulatory audits.
• Perform other related duties as assigned.
• Responsibilities may increase in scope.

Skills

Regulatory compliance

Technical writing

Project management

Cross-functional teamwork

Time management

Communication

Adaptability

Education

Bachelor's degree in science or engineering

Tools

Microsoft Office

Validation software

Documentation tools

Job description

Serán BioScience is expanding and seeking a Quality Assurance Engineer to join a cross-functional team responsible for qualification and validation of facilities, utilities, equipment, processes, cleaning, and computerized systems for the Commercial Manufacturing Facility.

You will generate risk assessments, URS, CQ plans, change controls, SOPs, CAPAs, and support audits while mentoring colleagues and driving process improvements to maintain validated state and regulatory compliance.