Laboratory Instrumentation & Validation Specialist

Pharmgate; Omaha (NE); On-site; USD 75,000 - 110,000; Full time

Job summary

Pharmgate Inc in Omaha, NE seeks Laboratory Equipment Specialist to maintain and optimize complex instrumentation, ensuring compliant analytical operations and timely calibrations.

You will collaborate with service engineers and QC teams, perform calibrations, maintenance, validations, and SOP adherence. Bachelor's in science and 3-5 years in FDA-regulated labs required.

This exempt, full-time role offers dedicated team and opportunity to move external support in-house.

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.
• Proficient with high-level lab equipment and SOPs/GMPs.

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.
• Work with laboratory 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 the Senior Scientist and Laboratory Manager as needed.
• Perform other duties as assigned.

Skills

Excellent organizational skills

Advanced knowledge of high-level lab設備

SOPs and GMP compliance

Time management

Verbal and written communication

Reading/understanding English docs

FDA & cGMP compliance understanding

MS Office & SAP B1

Education

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

Tools

HPLCs

SAP Business One

Microsoft Office

Job description

Pharmgate Inc in Omaha, NE seeks Laboratory Equipment Specialist to maintain and optimize complex instrumentation, ensuring compliant analytical operations and timely calibrations.

You will collaborate with service engineers and QC teams, perform calibrations, maintenance, validations, and SOP adherence. Bachelor's in science and 3-5 years in FDA-regulated labs required.

This exempt, full-time role offers dedicated team and opportunity to move external support in-house.