Engineer I, Validation

Serán BioScience • Bend, OR

3d • Onsite

About The Position

Serán is seeking an Engineer Associate or Engineer I to support validation activities for pharmaceutical manufacturing equipment, utilities, computerized systems, facilities, and processes. This role helps maintain, schedule, and execute qualification and validation activities for manufacturing tablets, capsules, and spray drying dispersion for clinical FDA trials. The successful candidate will support the validation lifecycle, including design, operation, continuous improvement, and decommissioning of manufacturing equipment. Pharmaceutical industry experience in a GMP environment is preferred, but applicants with the minimum education and experience are encouraged to apply. The job title and salary will be commensurate with pharmaceutical industry experience.

The position works with Facilities Engineering, Maintenance, and cross-functional teams to qualify equipment and support its release for GMP use. The role also contributes to lifecycle documentation, equipment readiness for technology transfers, investigations, CAPAs, change requests, and engineering projects. Work must comply with applicable GMP regulations and guidelines for systems qualification, cleaning, and process validation. Scope of work may increase to align with company initiatives.

Requirements

• Bachelor of Science degree in an engineering discipline.
• For Engineer I: a minimum of 1 year of previous GMP experience with a background in the pharmaceutical, biotech, chemical, validation, or QA industry.
• For Associate Engineer: no GMP experience is required, subject to the minimum education requirements.
• Ability to author qualification and validation protocols and reports.
• Mechanical aptitude and demonstrated problem-solving ability.
• Strong analytical skills, including the ability to interpret technical data and equipment performance trends.
• Excellent written communication skills for producing clear, compliant documentation.
• Ability to collaborate with cross-functional teams in a client-driven environment.
• Strong verbal and written communication skills.
• Excellent organizational skills, 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.
• Proficiency with Microsoft Suite or related software, and ability to learn new QMS systems.
• Consistent and predictable in-person attendance.
• Ability to work in cleanroom or controlled manufacturing environments as needed.
• Ability to occasionally lift equipment components up to approximately 25 lbs and stand for extended periods during equipment qualification or testing.
• Must be authorized to work for an employer in the U.S.; the employer is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

• Pharmaceutical industry experience within a GMP environment.

Responsibilities

• Collaborate with Facilities Engineering and Maintenance during equipment installation, calibration, and routine maintenance.
• Learn to develop and manage system lifecycle documentation, including 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 readiness for technology transfers, ensuring qualification aligns with client URS, 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 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 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, CAPAs, change requests, and engineering projects.
• Perform other related duties as assigned.

Benefits

• 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 are available with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level