Quality Assurance Validation Engineer @ Serán BioScience

Serán is seeking a Quality Assurance Validation Engineer to support validation activities of Operations instrumentation within GMP manufacturing. In this role you will be part of a cross functional team that will be involved in the development, execution, and/or approval of qualification and / or validation of facilities, utilities, equipment, process, cleaning, and computerized systems. You will also support validation lifecycle activities and will participate in the generation, review and/or approval of change controls, CAPAs, and deviations.

The development and execution of these deliverables requires direct communication with internal and external cross functional teams. Effective communication is essential for alignment on strategies and approaches, and correcting deficiencies while maintaining good working relationships. A thorough understanding of current regulations and guidelines such as 21 CFR Part 11, EudraLex Volume 4, Annex 15, and GAMP 5 is required.

Duties and Responsibilities

Generates and/or supports the generation of risk assessments, user requirements specifications (URS), validation plans, change requests, SOPs, CAPAs, and other relevant documents
Supports validation lifecycle activities to ensure that qualified systems remain in their validated state
Supports the qualification/validation effort driven by the MSAT group, including qualification of OSD systems, process validation, and cleaning validation
Provides support during clients and regulatory audits
Other related duties as assigned

Required Skills and Abilities

Comprehension of current regulations and guidelines (e.g., 21 CFR Part 11, 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 a minimum of two of the following: qualification of facilities, utilities, equipment and/or cleaning or process validation
Experience performing cleaning and/or process validation is preferred
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
Experience performing equipment qualification for OSD systems is required
Strong time-management skills and the ability to organize and coordinate multiple projects at a time
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 science, engineering, or related field with 3-5 years of experience in the pharmaceutical industry
Minimum of three years of experience performing qualifications and/or validations

Physical Requirements

Prolonged periods sitting at a desk and working on a computer
Prolonged periods of mobility between offices and campus buildings

Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

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. 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 pet programs as well.

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

Quality Assurance Validation Engineer

Serán BioScience

Duties and Responsibilities

Required Skills and Abilities

Education and Experience

Physical Requirements

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