Lead Laboratory Instrumentation & Validation Specialist

Serán BioScience; Bend (OR); On-site; USD 60,000 - 80,000; Full time

Job summary

Serán BioScience in Bend, Oregon is seeking a Laboratory Instrumentation and Validation Specialist to lead instrument validation and maintain regulatory compliance within a GMP environment. The role involves supervising a small team, troubleshooting laboratory instruments, and managing vendor relationships.

The ideal candidate will have a Bachelor's degree in a scientific field, several years of hands-on experience, and a strong understanding of FDA regulatory guidelines. Excellent communication skills and attention to detail are essential.

Qualifications

• Minimum 1-2 years of experience in a lead or supervisory position.
• 3-5 years of hands-on experience with analytical instrumentation.
• Thorough knowledge of cGMP’s and familiarity with 21 CFR Part 11.

Responsibilities

• Support data integrity, audit readiness of electronic systems.
• Lead onboarding and validation activities for laboratory equipment.
• Coordinate instrument repairs and preventive maintenance.

Skills

Experience supporting laboratory instruments in a QC environment

Hands-on experience with HPLC and FTIR

Excellent verbal and written communication skills

Strong analytical and problem-solving skills

Education

Bachelor’s degree in chemistry or engineering

Tools

Microsoft Office Suite

Job description

Serán BioScience in Bend, Oregon is seeking a Laboratory Instrumentation and Validation Specialist to lead instrument validation and maintain regulatory compliance within a GMP environment. The role involves supervising a small team, troubleshooting laboratory instruments, and managing vendor relationships.

The ideal candidate will have a Bachelor's degree in a scientific field, several years of hands-on experience, and a strong understanding of FDA regulatory guidelines. Excellent communication skills and attention to detail are essential.