Validation Specialist- III

Job Location:
Allston, MA (System Correction)

QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system. Its goal is to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets their needs and intended use.

• Coordinate activities relating to the qualification, calibration and maintenance of laboratory equipment and related systems.
• Coordinate the purchase, commissioning and introduction to service of new equipment.
• Establish and maintain Equipment History Files (EHF) for QC laboratory equipment.
• Be the contact point for instrumentation issues and provide training and troubleshooting support to the laboratory on new or existing instrumentation.
• Coordinate all services provided by vendors, ensuring vendors meet all site requirements.
• Schedule, plan and execute validation activities and preventive maintenance of laboratory equipment.

• Demonstrated scientific technical writing ability.
• Knowledge of USP 1058 and GAMP methodology.
• Knowledge of 21
  
  CFR Parts 11, 210, 211, 600 and 610.
• Experience with Empower and LIMS systems.
• Previous hands‑on experience performing laboratory equipment qualification.
• Proficient in Outlook, Microsoft Word and Excel, and lab‑based data management systems.
• Ability to gown and enter laboratory.
• May require off‑shift work to support activities.

Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline with 5 years of industry relevant experience OR Master's Degree in Chemistry, Life Sciences, or Engineering discipline with 3 years of industry relevant experience.

Minimum of 3 years of experience with analytical testing in a laboratory setting, such as HPLC, GC, Ion Chromatography, TOC, UV‑Vis, ELISA.