Search TSR Jobs

About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Lab Systems Quality Engineer

Job Description

  • Location: Devens, Massachusetts
  • Type: Contract
  • Job #82266

Our client, a leading pharmaceutical company, is hiring a Lab Systems Quality Engineer on a contract basis

Job ID #:  82266
 
Work Location: Devans, MA/100%ONSITE

Summary:

LAB SYSTEMS QUALITY ENGINEER

Requirements:

  • Perform analytical instrument computer system qualification in accordance with client procedures and under client supervision and guidance.

  • 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 includes laboratory and manufacturing buildings. 

  • Lead or provide supporting activities within the quality management system (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 qualification 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 within ServiceNow. 

  • 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 multiple projects and technical work assignments as a point of contact for project stakeholders. 

  • Provide local administrative support and liaison with 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. 

  • Knowledge of requirements for design, installation, Commissioning, and Qualification of computerized systems and equipment using risk-based approaches. 

  • Experienced in use of electronic systems for performing qualification Testing (e.g. ALM, ValGenesis, etc.). 

  • Service Provider shall comply with, perform services, and manage data under current ICH GxP guidelines, FDA rules, and client procedures. 

  • Generate project, lifecycle, and/or compliance deliverables for services listed in “Description of Services” section for all assigned projects and tasks, in accordance with agreed upon dates with client supervisor.

Skill/knowledge 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 and ability to embrace emerging technology. 

  • Must have experience or knowledge of requirements for working in a regulated environment application administration experience (configuring the application, performing 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) 

Location and Conditions 

  • •This Role is 100% Onsite

  • Estimated contract duration: 40 hours/week,  6 months subject to extend

  • Work Schedule: Mon – Fri, Business Hours 

  • Candidate will be required to report onsite 

  • Will require on a weekly basis to gown into manufacturing environment

Pay $64-65

Include a message to the recruiters.
Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.
Review our Privacy Policy for more information.
Review our Terms of Service for more information.

We are uploading your application. It may take a few moments to read your resume. Please wait!