Instrumentation & Validation Specialist

Pharmgate; Omaha (NE); On-site; USD 65,000 - 90,000; Full time

Job summary

Pharmgate is seeking a Laboratory Equipment Specialist to maintain complex instrumentation, perform calibrations, and ensure GMP compliance. You will collaborate with service engineers and quality teams while moving select functions in-house where feasible.

The role requires 3–5 years in an FDA-regulated lab, a science degree, and strong communication skills to train others and document activities in a timely manner.

Qualifications

• Bachelor of Science in Chemistry, Microbiology, Biology or related field.
• 3–5 years of experience in an FDA-regulated pharmaceutical laboratory facility or other highly regulated industry.
• Strong understanding of GMP and SOP requirements.

Responsibilities

• Maintain, perform, review and schedule calibrations for laboratory equipment.
• Develop and perform instrument maintenance, qualification and calibration procedures for existing and new equipment.
• Communicate with service engineers and outside contractors for maintenance and calibrations.
• Collaborate with management regarding instrumentation and service needs.
• Document analytical activities, calibrations and repairs accurately and timely.
• Support quality control and inspection activities related to instrumentation and metrology.
• Execute method validations as needed.
• Perform peer review of test methods as needed.
• Execute written protocols for method development and R&D as needed.
• Serve as backup to senior staff and laboratory manager as needed.
• Perform other duties as assigned.

Skills

Instrumentation troubleshooting

Calibrations & maintenance

SOPs & GMP compliance

Technical communication

English reading/writing

Education

Bachelor of Science in Chemistry, Microbiology, Biology or related field

Tools

Microsoft Office Suite

SAP Business One

Job description

Pharmgate is seeking a Laboratory Equipment Specialist to maintain complex instrumentation, perform calibrations, and ensure GMP compliance. You will collaborate with service engineers and quality teams while moving select functions in-house where feasible.

The role requires 3–5 years in an FDA-regulated lab, a science degree, and strong communication skills to train others and document activities in a timely manner.