What are the responsibilities and job description for the Lab Quality Systems Engineer position at Stellent IT LLC?
Title : "Lab Quality Systems Engineer"
Location : Devens, MA
Job description
Will require to gown into manufacturing environment to support benchtop systems qualification.
Must have experience or knowledge of requirements for working in a regulated environment application administration experience (configuring the application, preforming updates to the application, backend work)
Experience with computer or server administration (repairs to equipment, configurations within the server - folder permissions, Windows 7 / 10 / 11 Administration Knowledge)
Computer System or any Benchtop System Validation Experience
Requirements :
BS degree in life sciences, engineering or computer science field or equivalent experience
Minimum of 3 years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.
Commanding knowledge of SOPs, cGMPs, Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices to support working within a regulated environment.
Understanding of network, databases, servers, and PCs.
Strong capabilities for application administration and ability to embrace emerging technology.
Knowledge of requirements for design, installation, Commissioning, Qualification and Validation of computerized systems and equipment using risk-based approaches.
Proficient in use of HP-ALM Application to perform manual testing.
Ability to work independently and in a team environment at all levels of the organization.
Experience with administration of benchtop instrumentation applications ViCell
Lead or provide supporting activities within the quality management system ( Infinity )
Execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.
Ensure alignment with BMS directives and industry guidelines for applications.
Execute on technology improvements and efficiency opportunities to improve business and compliance.
Support administration of quality and laboratory applications including their software development life cycle activities and technical support.
Keep a pulse on the job market with advanced job matching technology.
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