Validation Specialist- III

• QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system.

• It's goal 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.

• This position is responsible for qualifying analytical and microbiological testing instrumentation for the company.

• These are some of the responsibilities:

• 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/execute validation activities and preventive maintenance of laboratory equipment.

Skills:

• Demonstrated scientific technical writing ability.

• Knowledge of USP 1058 and GAMP methodology.

• Knowledge of 21CFR Parts 11, 210, 211, 600 and 610.

• Experience with Empower and LIMS systems.

• Previous hands on experience performing laboratory equipment qualification.

• Proficient in Outlook and Microsoft Word and Excel and lab based data management systems.

• Ability to gown and enter laboratory

• May require off shift work to support activities

• Ability to gown and enter laboratory

• May require off shift work to support activities

Education:

• Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience Or
  
• Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 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.

For more information, please contact:

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3348 | Fax: 973.998.2599

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