Quality Assurance Engineer

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 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.

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 that qualified systems remain in their validated state.
• 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 clients and regulatory audits.
• Perform other related duties as assigned.
• Responsibilities may increase in scope to align with company initiatives.

Qualifications

• 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 the validation effort.
• Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort.
• Hands‑on experience with the 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 timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross‑functional team.
• Strong time‑management skills and the 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, with preference 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.

Benefits Summary

• 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.

Additional Information

• 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.