Validation Engineer

Validation Engineer

Sern BioScience is motivated to find an industry-experienced Validation Engineer to support the development of a new commercial manufacturing facility and existing clinical operations. Validation is a regulatory requirement and must be conducted in conformance to cGMPs and FDA requirements. The Validation Engineer operations will be part of a cross functional team that will plan and execute commissioning / qualification (CQ) projects for equipment and critical utilities process, tech transfer of manufacturing process from clinical to commercial site, and subsequent validation for process, cleaning, and computerized systems to support commercial distribution of non-sterile pharmaceutical products. Under the supervision of Operations Leadership, the Validation Engineer will be responsible for planning and execution of CQ and validation projects. In order to perform this task, applicants require a thorough understanding of the manufacturing processes and systems as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements. Successful candidates will understand that the development and execution of CQ and validation projects requires communication with internal and external cross functional teams. Demonstrated ability with effective communication is essential for identifying required information, alignment of strategies, and mitigation risks while maintaining good working relationships.

Duties and Responsibilities

• Leads the commissioning and qualification (C&Q) of new and existing equipment and systems for OSD manufacturing, facilities, and utilities, ensuring compliance with cGMP, FDA, and EU regulatory standards
• Supports the clinical technology transfer and operations in design, scale-up, optimization, and troubleshooting of OSD processes and equipment
• Develops and executes protocols for equipment IQ / OQ / PQ in alignment with site validation master plans and project timelines
• Collaborates with cross-functional teams to define equipment specifications, user requirements (URS), and establish project timelines and budgets
• Manages installation activities, equipment FAT / SAT execution, and vendor coordination to ensure technical and compliance requirements are met
• Collaborates with multidisciplinary team to complete change controls, deviations investigations, and CAPAs as required
• Supports regulatory inspections and client audits
• Performs other related duties as assigned
• Responsibilities may increase in scope to align with company initiatives

Required Skills and Abilities

Education and Experience

Physical Requirements

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 : Sern 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. Sern 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.

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

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