---
title: 'Senior Validation Engineer at Serán BioScience'
canonical: 'https://feeny.ai/job/senior-validation-engineer-seran-bioscience-bend-0nzx2j3zjf09'
type: 'job'
last_seen: '2026-09-11'
---

# Senior Validation Engineer at Serán BioScience

- **Company:** Serán BioScience
- **Location:** Bend, OR
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-01-24
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/seranbio/a2cab472-b096-4ac4-bf53-3a582b1217f3

## Job description

Serán BioScience is motivated to find an industry-experienced Validation Engineer to support the development of a new commercial manufacturing facility. The Senior Validation Engineer 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. Experience will determine title and salary, with preference given to applicants with over 8 years of experience with Oral Solid Dosage and an interest in leading teams. Those with less experience are encouraged to apply.

As a critical member of the Commercial Steering Committee, the Senior 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 8 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
- 8 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

## About Serán BioScience

## Company Overview
- **One-liner**: Serán BioScience is a science-driven drug development partner providing integrated formulation, particle engineering, and clinical manufacturing services to pharmaceutical and biotechnology companies.
- **Entity Type**: Private (Privately Held)
- **Headquarters**: Bend, Oregon, United States
- **Founded**: 2016
- **Founders**: Dr. Smithey (President, CEO, and Co-founder)

## Core Business
- **Primary Industry**: Biotechnology / Drug Development (Contract Development and Manufacturing Organization – CDMO)
- **Target Customers**: B2B – Pharmaceutical and biotechnology companies (from preclinical to commercial stage)
- **Mission**: To provide optimized drug development and manufacturing services for clients, from discovery to the clinic, using a science-first approach to accelerate medicines to patients.

## Products & Services
- **Preformulation Services**: Physicochemical characterization and early feasibility studies to guide formulation strategy.
- **Formulation Development**: Design of robust formulations for poorly soluble compounds using spray drying, hot melt extrusion, fluid bed processing, granulation, and solid dosage forms (tablets, capsules, multiparticulates).
- **Particle Engineering**: Custom-built spray dryers capable of producing nano-to-micro particles; expertise in spray-dried dispersions and engineered particles for inhalation.
- **Clinical Manufacturing**: cGMP manufacturing of clinical trial materials (suspensions, capsules, tablets) with on-site ICH stability storage.
- **Commercial Manufacturing**: A 100,000 sq ft commercial manufacturing campus under construction, including large-scale spray drying for late-stage clinical and commercial supply.
- **Quality Control Laboratory**: Full release, stability, and microbial testing capabilities.

## Market Standing
- **Valuation/Market Cap**: Not publicly available
- **Key Metric**: Total Funding – Not disclosed; Headcount of 146 employees (+0.6% YoY as of latest LinkedIn data)
- **Notable Investors/Partners**: Not publicly disclosed
- **Growth Signals**: Constructing a 100,000 sq ft commercial manufacturing facility; expanding team to over 200 members; adding new development facilities and quality control labs; LinkedIn follower growth of +29.1% year-over-year.

## Competitive Advantages
- **Science-First Approach**: Employs predictive design tools, novel chemistry, and advanced analytical methods from the earliest stages to de-risk development.
- **Particle Engineering Leadership**: Decades of experience with poorly soluble compounds; proprietary spray drying and particle engineering technologies (nano-structures to micro-particulates).
- **End-to-End Support**: Integrated services from preformulation through commercial manufacturing, reducing handoffs and timelines.
- **Right From the Start™ Methodology**: Parallel development of drug product intermediates and final dosage forms to accelerate programs.

## Strategic Focus
- **Commercial Scale-Up**: Investing in a dedicated commercial manufacturing campus to support clients’ late-stage and marketed products.
- **Technology Expansion**: Continuously expanding technical capabilities (spray drying, hot melt extrusion, fluid bed processing) and facility footprint.
- **Talent Acquisition**: Growing the team of scientists, engineers, and support staff to serve an increasing pipeline of complex drug molecules.

## Why Work Here
- **Culture**: Collaborative, respectful, and fun environment where every role contributes to delivering novel therapies. Emphasis on mentoring and continuous learning.
- **Work-Life Balance**: Central Oregon lifestyle with outdoor recreation access; standard business hours (with alternative shifts in manufacturing/QC/QA).
- **On-Site Requirement**: All employees are expected to work on the Bend campus; remote flexibility considered on a case-by-case basis.
- **Benefits**: Paid time off, employer retirement contributions (no match or vesting required after 90 days), fully funded medical/dental/vision for employee and household, basic life and long-term disability, Employee Assistance Program.
- **Ideal Applicant**: Scientific background with GLP/GMP knowledge; inquisitive problem-solver who follows SOPs and collaborates toward common goals.

## Sources
1. [seranbio.com](https://www.seranbio.com/about)
2. [linkedin.com](https://linkedin.com/company/seran-bioscience)
3. [seranbio.com](https://www.seranbio.com/careers)
4. [seranbio.com](https://www.seranbio.com/?portfolioCats=34%2C23%2C29%2C35%2C22%2C24%2C30%2C25%2C28%2C31)
5. [jobs.lever.co](https://jobs.lever.co/seranbio)

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