Laboratory Equipment & Validation Specialist

Pharmgate Inc•Omaha, NE

11d

About The Position

The Laboratory Equipment Specialist maintains and optimizes complex laboratory instrumentation to support accurate, efficient, and compliant analytical operations. Working closely with laboratory peers, the specialist serves as a primary instrumentation technical support resource and helps ensure that preventive maintenance and calibration are completed on time and in compliance. The role focuses on calibration, repair, qualification review, and troubleshooting of higher-level laboratory equipment, in collaboration with service engineers and quality laboratory teams. It supports laboratory management and requires independent application of advanced scientific knowledge while following SOPs, GMPs, and other applicable industry and company regulations. The specialist also evaluates and recommends ways to bring external support functions in-house where feasible.

Requirements

Bachelor of Science in Chemistry, Microbiology, Biology, or a related field.
3–5 years of experience in an FDA-regulated pharmaceutical laboratory facility or another highly regulated industry.
Advanced knowledge of high-level laboratory equipment such as HPLCs.
Ability to follow Standard Operating Procedures (SOPs) and GMP guidelines.
Thorough understanding of FDA and cGMP compliance regulations.
Excellent organizational skills and attention to detail.
Excellent time management skills and a proven ability to meet deadlines.
Strong verbal and written communication skills and ability to work with personnel at all levels.
Strong analytical and problem-solving skills, including ability to understand instructions and materials in English and perform arithmetic using whole numbers, common fractions, and decimals.
Ability to function well in a fast-paced and sometimes stressful environment.
Proficiency with Microsoft Office Suite, virtual meeting applications, SAP Business One, and related software.

Responsibilities

Provide guidance on instrumentation troubleshooting and repairs to support daily laboratory efficiency.
Provide on-the-job training and SOP review as needed.
Collaborate with the Laboratory Senior Scientist to convey technical knowledge and help develop training materials.
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 regarding maintenance and calibrations.
Work with laboratory management regarding impacted instrumentation and service needs.
Document analytical activities, calibrations, and repairs accurately and promptly.
Support quality control and inspection activities related to analytical 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.