Lab Validation Technician - 4 LOCS

Job Description

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