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Validation (CSV) Specialist

Gwynedd, PA

Posted: 02/28/2023 Job Number: 23223269

Job Description

100% Onsite.
Deep expertise and experience handling Computer System Validations of Laboratory Systems.

Required Skills:
  • B.S. Degree in the 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.
  • 4+ years of experience Validating LCMS systems; experience with Analyst application preferred.
  • Experience working within a GLP or GMP laboratory.
  • Experience maintaining Laboratory Equipment including plate readers, automated liquid handlers, and 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.

Project Description:
  • Candidate will work within the PCD metrology team that supports regulated equipment and systems used within GxP regulated laboratories including robotics automation.
  • Primary focus will be participating in and driving computer system validation efforts associated with laboratory computerized systems, robotic automation, including LCMS systems, liquid handlers, plate readers/imagers, qPCR, flow cytometer, etc.
  • Developing a working understanding of laboratory equipment and software applications validation.
  • Working with equipment vendors to appropriately setup system 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 executing 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 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 audit.
  • Author SOPs associated with laboratory equipment or related processes.
  • Operate within the confines of departmental SOPs and regulatory guidance's.
  • 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.
  • Experience validating computerized systems within a regulated environment operating under SOPs and procedures.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.Com


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Cheryl Ambrose

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