Serán 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

Demonstrates knowledge of cGMPs guidelines and regulations acquired through education, experience, and training
Preference for those who posses knowledge of Global Regulatory requirements (E.g., FDA / MHRA / EMEA)
Showcases foundational understanding of the compliance and technical requirements for the application of various scientific concepts used in developing different dosage forms of pharmaceutical products (primarily oral solid dose, while experience with sterile products is desired)
Experience with regulatory expectations and industry practices for CQ and Validation using Product Lifecycle approach
Experience with designing CQV plans for Facilities, Utilities, and Process equipment desired
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 once
Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
Ability to prioritize tasks and to keep leadership apprised of performance timelines
Accepts feedback from a variety of sources and constructively manages conflict
Demonstrates leadership skills with ability to motivate and coach cross functional teams
Experience in FAT/SAT of process equipment, and knowledge operating principles of typical OSD process equipment preferred.
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 relevant technical field
Requires a minimum of 5 years of quality, validation, or engineering experience in non-sterile clinical and commercial pharmaceutical manufacturing
Fundamental understanding of process equipment, utilities, manufacturing process, cleaning process and Quality systems used in the pharmaceutical/biotech industry
5 years of GMP compliance experience, including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others

Physical Requirements

Prolonged periods of sitting or standing at a desk and working on a computer
Prolonged periods of sitting or standing in a manufacturing environment
Must be able to lift fifteen pounds at times
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 our employees’ wellbeing, along with access to pet insurance.

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

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Serán BioScience

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Validation Engineer