Quality Assurance Engineer

Serán Bio Science 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;
Eudra Lex Volume 4, Annex 15; and GAMP 5.

• 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.

• Understanding of current regulations and guidelines (e.g., 21 CFR Parts 11, 210, and 211, Eudra Lex 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.

• 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.

• 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  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.

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 Bio Science 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.