Serán BioScience

CDMO offering drug formulation & manufacturing

Engineer 1 - Validation

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBend, OR, USANo salary listedIn-person

About the Job

Requirements

A Bachelor of Science degree in an engineering discipline is required.
Engineer I candidates must have at least one year of previous GMP experience and a background in the pharmaceutical, biotechnology, chemical, validation, or quality assurance industry.
Demonstrate mechanical aptitude and the ability to solve problems.
Have strong analytical skills and the ability to interpret technical data and equipment performance trends.
Have written communication skills for generating clear, compliant documentation.
Work collaboratively with cross-functional teams in a client-driven environment.
Have strong verbal and written communication skills.
Have organizational skills, attention to detail, and a commitment to documentation accuracy.
Prioritize work independently and ask for assistance when appropriate.
Focus in a fast-paced environment with shifting priorities.
Be proficient with Microsoft Suite or related software and able to learn new quality management systems.
Adhere to consistent and predictable in-person attendance.
Be able to work in cleanroom or controlled manufacturing environments as needed.
Be able to lift equipment components up to approximately 25 pounds occasionally and stand for extended periods during equipment qualification or testing.
Be authorized to work for an employer in the United States; employment visa sponsorship is not available.

Responsibilities

Collaborate with Facilities Engineering and Maintenance during equipment installation, calibration, and routine maintenance.
Learn to manage system lifecycle documentation, including User Requirements, Functional and Design Specifications, Testing Protocols (Cx/IQ/OQ/PQ), Traceability Matrices, Qualification Summary Reports, Change Control, and Risk Assessments.
Support equipment readiness for technology transfers, ensuring qualification aligns with client User Requirements, process needs, and regulatory expectations.
Perform equipment testing, collect and analyze data, and confirm performance against specifications and process requirements.
Maintain validation documentation, including protocols, reports, traceability metrics, and equipment lifecycle records.
Assist with generating and maintaining standard operating procedures 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 for Systems Qualification, Cleaning, and Process Validation.
Ensure equipment is released for GMP use within agreed-upon timelines following qualification and cleaning activities.
Perform investigations, corrective and preventive actions, change requests, and engineering projects.

Desired Qualifications

Pharmaceutical industry experience within a GMP environment is preferred.

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 the Company

Serán BioScience

CDMO offering drug formulation & manufacturing

Serán Bioscience is a contract development and manufacturing organization that helps pharmaceutical companies develop and manufacture drugs. It offers preformulation, formulation and dosage-form development, spray drying and particle engineering, plus cGMP manufacturing and analytical quality control. It relies on flexible, client-tailored services and a broad technical toolkit to support a range of clients from startups to large pharma. Its goal is to enable efficient, compliant drug development and production with rigorous quality standards.

Company size: 51-200
Company stage: Growth Equity (Venture Capital)
Total funding: $200M
Headquarters: Bend, OR
Founded: 2016

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