Entry-Level Pharma GMP Validation Engineer

Serán BioScience; Bend (OR); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

PTO (paid time off)

Retirement plan contributions after 90

Health plans with employee sharing

Life insurance & long-term disability

Employee Assistance Program + pet-ins

Job summary

Serán BioScience, based in Bend, Oregon, seeks an Engineer Associate or Engineer I to support qualification and validation activities for pharmaceutical manufacturing equipment, utilities, and processes. You will help maintain and execute the validation lifecycle, including design, operation, continuous improvement, and decommissioning in a GMP environment.

Preference is given to candidates with pharmaceutical experience; those with minimal education and experience are encouraged to apply.

Qualifications

• Requires BS in Engineering or related field.
• 1 year of GMP exposure for Engineer I; 0 GMP for Associate Engineer with appropriate education.
• Experience with qualification/validation in pharma preferred but not required.

Responsibilities

• Collaborate with Facilities Engineering during equipment installation, calibration, and maintenance.
• Develop and manage system lifecycle documentation (URS, FDS, IQ/OQ/PQ, TRACE matrices).
• Support readiness for tech transfers and ensure qualification aligns with URS and regulatory expectations.
• Conduct equipment testing, data collection, and analysis to verify performance against specs.
• Maintain validation documentation (protocols, reports, traceability) and SOPs.
• Work with cross-functional teams to troubleshoot equipment, process, and validation issues.
• Ensure GMP compliance and on-time release of equipment for GMP use.
• Perform investigations, CAPAs, change requests, and engineering projects.

Skills

Mechanical aptitude

Analytical skills

Written communication

Cross-functional collaboration

Problem solving

Education

BS in Engineering

Tools

Microsoft Suite

QMS systems

Job description

Serán BioScience, based in Bend, Oregon, seeks an Engineer Associate or Engineer I to support qualification and validation activities for pharmaceutical manufacturing equipment, utilities, and processes. You will help maintain and execute the validation lifecycle, including design, operation, continuous improvement, and decommissioning in a GMP environment.

Preference is given to candidates with pharmaceutical experience; those with minimal education and experience are encouraged to apply.