Please login/register to apply for this job.
30 Sep 2021

Temporary Lab System Engineer (21-27295)

iris.chen@axelon.com Devens, Massachusetts, United States

Job Description

Job Description:

Job Responsibilities:
• Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as ViCell, SoloVPE, Cary60, and Spectramax plate readers throughout the site which include laboratory and manufacturing buildings.
• Lead or provide supporting activities within the quality management system (Trackwise & Infinity)
• Liaison with global partners within the Client organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation lifecycles and training.
• Provide ownership of assets and utilize Client systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems.
• 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 Client directives and industry guidelines for applications.
• Execute and lead multiple projects and technical work assignments as a point of contact for project stakeholders.
• Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration.
• Provide digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, and cyber security.
• 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.

Requirements:

• BS degree in life sciences, engineering or computer science field or equivalent experience.
• Minimum of 5+ 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; usage of applications such as Empower and NuGenesis and ability to embrace emerging technology.
• Proven leadership skills and the ability to negotiate in a complex environment.
• Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications.
• Ability to plan and lead multiple projects of high complexity with matrix teams successfully.
• Self-driven and capable of prioritizing with system and business analysis skills applying lean and OpEx principles.
• Excellent project management, communication, and technical writing skills are required.
• Possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management utilizing oral and written communications.
• Excellent analytical, problem-solving, and critical thinking skills requiring the ability to pay attention to detail.
• Ability to work independently and in a team environment at all levels of the organization, with the capability to provide oversight to contractors as applicable.

How to Apply

Please share Resumes to Iris.chen@axelon.com to apply.

Job Types: Temporary.

Job expires in 25 days.

66 total views, 1 today

Apply for this Job