Laboratory Instrumentation and Validation Specialist

Recruits, interviews, hires, and trains new staff in accordance with company procedures. 

Oversees daily workflow, assigns tasks, and manages resource planning.   

Provides constructive and timely performance evaluations. 

Handles discipline and termination of employee in accordance with company policy. 

Ensures team compliance with training requirements, safety programs and GMP expectations 

Support data integrity, audit readiness, and lifecycle management of electronic laboratory systems and analytical equipment. 

Leads instrument onboarding, installation, qualification, and computer system validation (CSV) activities for new or modified laboratory equipment and software systems.  

Authors, reviews, and maintains validation documentation, ensuring alignment with GAMP and GxP expectations. 

Performs routine and non-routine troubleshooting of laboratory instruments to identify root causes, restore operation, and minimize downtime. 

Coordinate and oversees instrument repairs, preventive maintenance, and service activities with internal teams and external vendors.  

Supports calibration and metrology programs, including scheduling, documentation review, and management of out-of-tolerance events. 

Owns or contributes to deviations, investigations, CAPAs, and change controls related to laboratory equipment and computerized systems. 

Maintains and updates SOPs, work instructions, and related documentation to ensure compliance and operation consistency. 

Participates in internal and external audits, providing documentation, subject-matter expertise, and corrective action support. 

Manages vendor relationships, service contracts, and provides budgetary input for equipment lifecycle planning.  

Experience supporting laboratory instruments in a QC or regulated laboratory environment. 

Familiarity with CSV, instrument qualification, and GMP documentation expectations.