VALIDATION (CSV) SPECIALIST GWYNEDD, PA 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
ALPHA'S REQUIREMENT #23-00444
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
