Manufacturing Technician I

3383 Shire Human Genetic TherapiesLexington, MA
Onsite

About The Position

This role is responsible for carrying out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include execution of routine production operations, performing Batch Record and Form Prep requests, entering data in the Laboratory Information Management System (LIMS), recording data into log books, sample preparation and testing, proposing document revisions, completing required training on time, and carrying out work in a safe manner, notifying management of safety issues and risks. Additionally, the role involves managing equipment and supporting facility-related projects by initiating work orders, performing scheduled cleaning and standardization of equipment, supporting change over activities, and assisting in the assembly and disassembly of process equipment. The role also includes staff technical training and development, which involves meeting and maintaining training requirements, developing and maintaining a personal development plan, and providing an annual performance self-assessment on the development plan.

Requirements

  • cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps
  • Data entry into Laboratory Information Management System (LIMS)
  • Data recording into log books
  • Sample preparation and testing
  • Document revision proposals
  • Timely completion of required training
  • Safe work practices and reporting of safety issues/risks
  • Initiating work orders for equipment and facility projects
  • Scheduled cleaning of equipment
  • Standardization of equipment
  • Support for change over activities
  • Assistance with assembly and disassembly of process equipment
  • Meeting and maintaining training requirements
  • Developing and maintaining a personal development plan
  • Providing annual performance self-assessment on development plan

Responsibilities

  • Execution of routine production operations
  • Perform Batch Record and Form Prep requests
  • Enter data in the Laboratory Information Management System (LIMS)
  • Record data into log books
  • Sample preparation and testing
  • Propose document revisions
  • Complete required training on time
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Initiating work orders
  • Perform scheduled cleaning of equipment
  • Perform standardization of equipment
  • Support change over activities
  • Assist in the assembly and disassembly of process equipment
  • Meet and maintain training requirements
  • Develop and maintain personal development plan
  • Provide annual performance self assessment on development plan

Benefits

  • Equitable pay
  • Transparency in pay practices
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