---
title: 'Engineer I, Validation at Serán BioScience'
canonical: 'https://feeny.ai/job/engineer-i-validation-seran-bioscience-bend-wv81tyase36c'
type: 'job'
last_seen: '2026-11-06'
---

# Engineer I, Validation at Serán BioScience

- **Company:** Serán BioScience
- **Location:** Bend, OR
- **Work type:** onsite
- **Posted:** 2026-11-03
- **Last confirmed live:** 2026-11-06
- **Apply:** https://jobs.lever.co/seranbio/b3be57ea-0aa0-480e-bb85-ccc075f1af91

## Job description

Serán is seeking an Engineer Associate or Engineer I to support validation activities associated with pharmaceutical manufacturing equipment, utilities, computerized systems, facilities, and processes. This position is a crucial role in maintaining, scheduling, and executing qualification and validation activities for the manufacturing of tablets, capsules and spray drying dispersion for the use of clinical FDA trials. The successful candidate will support all facets of the validation life cycle including design, operation, continuous improvement, and decommissioning of manufacturing equipment. Preference will be given to candidates with pharmaceutical industry experience within a GMP environment to best inform decisions and provide direction for the assurance of product quality. While industry experience is preferred, those with minimum education and experience are encouraged to apply.  Serán seeks applicants who demonstrate an aptitude to apply their engineering education and background to a new industry and gaining experience in cGMP regulatory environment. Job title and salary commensurate on experience within pharmaceutical industry.

Duties & Responsibilities

- Collaborate with Facilities Engineering and Maintenance during equipment installation, calibration, and routine maintenance
- Assist with the develop and learn to manage system lifecycle documentation consisting of User Requirements (URS), Functional and Design Specifications, Testing Protocols (Cx/IQ/OQ/PQ), Traceability Matrix, Qualification Summary Reports, Change Control, and Risk Assessments
- Support equipment reediness for tech transfers, ensuring qualification aligns with client URS, process needs, and regulatory expectations
- Perform equipment testing, data collection, and analysis to confirm performance against specifications and process requirements
- Maintain complaint validation documentation, including protocols, reports, traceability metrics, and equipment lifecycle
- Assist with the generation and maintenance of SOPs and supporting documents
- Work with cross-functional teams to troubleshoot equipment, process, and validation issues
- Perform job responsibilities in compliance with applicable GMP regulations and guidelines as applied to the fields of Systems Qualification, Cleaning, and Process Validation
- Ensure equipment is released for GMP use within agreed-upon timelines following qualification and cleaning activities
- Perform investigations, CAPAs, change requests, and engineering project
- Scope of work may increase to align with company initiatives
- Perform other related duties as assigned

Required Skills and Abilities

- Authors qualification and validation protocols and reports
- Demonstrates mechanical aptitude with a proven ability to problem-solve
- Strong analytical skills with the ability to interpret technical data and equipment performance trends
- Excellent written communication skills for generating clear, compliant documentation
- Ability to work collaboratively with cross-functional teams in a client-driven environment
- Strong verbal and written communication skills
- Excellent organizational skills with attention to detail and commitment to documentation accuracy
- Ability to prioritize work independently and ask for assistance when appropriate
- Ability to focus in a fast-paced environment with shifting priorities
- Proficient with Microsoft Suite or related software, with the ability to learn new QMS systems

Education & Experience

- BS Degree in Engineering discipline
- Engineer I qualifications amount to a minimum of 1 year of previous GMP experience with background in the Pharmaceutical, Biotech, Chemical, Validation, or QA industry
- Associate Engineer qualifications require 0 GMP experience with the minimum education requirements

Physical Requirements

- Adheres to consistent and predictable in-person attendance
- Ability to work in cleanroom or controlled manufacturing environments as needed
- Occasional lifting of equipment components (up to ~25 lbs).
- Ability to stand for extended periods during equipment qualification or testing.

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon. 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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