Lab Validation Technician

3 weeks ago

West Point, United States NavitsPartners Full time

Position: Lab Validation Analyst
Location: West Point, PA 19486
Duration: 12 months

Job Description:

  • Candidate will work within the PCD metrology team that supports regulated equipment and systems used within a GxP regulated laboratories including robotics automation
  • Primary focus will be participating in and driving computer system validation efforts associated with laboratory computerized systems, and robotic automation, including LCMS systems, liquid handlers, plate readers/imagers, qPCR, flow cytometer, etc..
  • Activities will include:
  • Developing a working understanding of laboratory equipment and software application validation
  • Working with equipment vendors to appropriately set up systems within a GxP environment
  • Generating and/or updating system requirements
  • Partnering with IT to establish system accounts and data flow pathways, with a focus on data integrity principles
  • Partnering with document writers, IT, and Quality in the generation, review, and execution of system validation acceptance test documents
  • Gain a working knowledge of laboratory equipment to facilitate troubleshooting and/or perform maintenance or calibration activities
  • Support the purchase, installation, and equipment qualification of new laboratory equipment
  • Partner with facilities staff on the buildout of new labs or renovation of existing laboratories
  • Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training, and cross-site support
  • Represent the laboratory on all aspects of laboratory equipment and system validation during the audit
  • Author SOPs associated with laboratory equipment or related processes
  • Operate within the confines of departmental SOPs and regulatory guidance
  • Utilize electronic applications (Electronic Lab Notebooks, Procal, etc.) to input and retain calibration documentation
  • System validation efforts may be for new system implementation, or part of change controls to upgrade or retire existing systems.
  • Individuals should have experience validating computerized systems within a regulated environment operating under SOPs and procedures.

Qualification:

  • B.S. Degree in Biology, Biochemistry, Analytical Chemistry, Chemistry, or related sciences with at least 3 years of industry experience or an M.S. with 1-2 years of related experience.
  • Years of experience: 4+ (including experience validating LCMS systems; experience with Analyst application preferred).

Required Experience and Skill:

  • Experience working within a GLP or GMP laboratory
  • Deep expertise and experience handling computer system validations of laboratory systems
  • Experience maintaining laboratory equipment including plate readers, automated liquid handlers, or other specialized computerized systems
  • Capable of working independently under moderate supervision
  • Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators

 

 

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