Quality Assurance Engineer

Serán BioScience; Bend (OR); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid time off

Health plans

Retirement contributions

Life and long-term disability coverage

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience in Bend, Oregon is looking for a Quality Assurance Engineer to join their team. This role focuses on supporting the Commercial Manufacturing Facility while ensuring compliance with industry regulations and guidelines. The ideal candidate will have proven experience in facilities, utilities, and process validations.

The QA Engineer will work closely with cross-functional teams to maintain effective communication and relationships while driving process improvements. This position offers benefits such as over four weeks of paid time off, health plans, and retirement contributions.

Qualifications

• Bachelor’s degree in a relevant field.
• Minimum of 4 years in the pharmaceutical industry.
• Experience in validation and qualifications.

Responsibilities

• Generate risk assessments and user requirement specifications.
• Support validation lifecycle activities.
• Drive process improvement initiatives.
• Provide support during audits.

Skills

Understanding of current regulations

Technical writing skills

Hands-on experience with qualifications

Time-management skills

Effective communication

Ability to prioritize tasks

Conflict management

Education

Bachelor’s degree in a science or engineering

4 years experience in pharmaceuticals

Tools

Microsoft Office

Enterprise systems

Job description

Serán BioScience is expanding and looking for a Quality Assurance Engineer with industry experience to join at this exciting time. The QA Engineer will be part of a cross‑functional team responsible for the review and/or approval of qualification/validation of all lifecycle activities associated with facilities, utilities, equipment, process, cleaning, and computerized systems. The focus of this position will be to support the Commercial Manufacturing Facility that is currently underway.

Successful candidates will demonstrate effective communication with internal and external cross‑functional teams, align strategies and approaches, correct deficiencies, and maintain good working relationships. They will have a thorough understanding of current regulations and guidelines such as 21 CFR Parts 11, 210, and 211; EudraLex Volume 4, Annex 15; and GAMP 5.

Duties And Responsibilities

• Generate and/or support the generation of risk assessments, user requirements specifications (URS), C&Q plans, change controls, SOPs, CAPAs, and other relevant documents.
• Support validation lifecycle activities such as change management, periodic reviews, and re‑qualification to ensure systems remain validated.
• Make compliance decisions to support commercial operations.
• Mentor colleagues on the reasons or justifications of the requirements and practices.
• Drive process improvement initiatives.
• Provide support during client and regulatory audits.
• Perform other related duties as assigned.
• Responsibilities may increase in scope to align with company initiatives.

Required Skills And Abilities

• Understanding of current regulations and guidelines (e.g., 21 CFR Parts 11, 210, and 211, EudraLex Volume 4 – Annex 15, GAMP 5, etc.) and how to apply them to support validation effort.
• Technical writing skills to develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support validation.
• Hands‑on experience with qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation; experience in at least two of these areas is required.
• Ability to manage multiple projects, create and work within internal timelines, solve problems, deliver on commitments, and utilize interpersonal skills in a cross‑functional team.
• Strong time‑management skills and ability to organize and coordinate multiple projects at a time.
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company.
• Ability to prioritize tasks and keep leadership apprised of performance to timelines.
• Accepts feedback from a variety of sources and constructively manages conflict.
• Experience in Oral Solid Dose operations and spray drying is preferable.
• Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems.

Education And Experience

• Bachelor’s degree in a science, engineering, or related field.
• Minimum of 4 years required within the pharmaceutical industry; preference is given to those with 5–10 years of experience.
• Minimum of 4 years of experience performing qualifications and/or validations is required.

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer.
• Prolonged periods of mobility between offices and campus buildings.
• Adheres to consistent and predictable in‑person attendance.

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Level And Compensation Will Be Based On Experience.

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 employees’ wellbeing, along with access to pet insurance.

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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.