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