Pharmaceutical Validation Engineer I

Serán BioScience; Bend (OR); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Paid time off (four weeks)

Retirement contributions after 90 days

Various health plans

Basic life and long-term disability

Employee Assistance Program with pet保险

Job summary

Serán BioScience in Bend, Oregon seeks an Engineer Associate or Engineer I to support validation activities for pharmaceutical manufacturing equipment and processes. The role covers design, operation, and decommissioning of qualification activities for tablets, capsules, and spray drying dispersion used in clinical trials.

You will collaborate with Facilities Engineering to prepare URS, IQ/OQ/PQ, Change Control, CAPAs, and ensure GMP-regulated documentation.

Qualifications

• Authors qualification and validation protocols and reports.
• Demonstrates mechanical aptitude with a problem-solving mindset.
• Strong analytical skills to interpret technical data and equipment performance trends.
• Excellent written communication for compliant documentation.
• Ability to collaborate with cross-functional teams in client-driven environments.

Responsibilities

• Collaborate with Facilities Engineering and Maintenance during installation, calibration, and routine maintenance.
• Develop and manage system lifecycle documentation (URS, SFD, IQ/OQ/PQ, Traceability Matrix, Cx reports, Change Control, Risk Assessments).
• Support equipment readiness for tech transfers, ensuring qualification aligns with URS and regulatory expectations.
• Perform equipment testing, data collection, and analysis to verify performance against specifications.
• Maintain validation documentation (protocols, reports, traceability metrics, lifecycle).
• Assist with SOPs and related documents; troubleshoot issues with cross-functional teams.
• Ensure GMP compliance and timely release for GMP use following qualification and cleaning activities.
• Perform investigations, CAPAs, change requests, and engineering projects.
• Scope may increase with company initiatives; perform other related duties.

Skills

Qualification protocols & reports

Mechanical aptitude

Data analysis

Regulatory documentation

Cross-functional collaboration

Written communication

MS Suite proficiency

QMS learning ability

Education

BS Degree in Engineering

1 year GMP experience (Engineer I)

0 GMP experience (Associate Engineer)

Tools

Microsoft Office

Job description

Serán BioScience in Bend, Oregon seeks an Engineer Associate or Engineer I to support validation activities for pharmaceutical manufacturing equipment and processes. The role covers design, operation, and decommissioning of qualification activities for tablets, capsules, and spray drying dispersion used in clinical trials.

You will collaborate with Facilities Engineering to prepare URS, IQ/OQ/PQ, Change Control, CAPAs, and ensure GMP-regulated documentation.