Laboratory Operations Technician III (Hybrid - Acton, MA)

Insulet CorporationActon, MA
1d$23 - $34Hybrid

About The Position

This person is responsible for supporting the engineering teams in creating comprehensive documentation for lab equipment. This role serves as the primary resource for engineering staff, offering guidance on tool management processes, documentation, and equipment procurement. Key responsibilities include organizing and maintaining equipment files within the Product Lifecycle Management (PLM) system, ensuring accuracy and completeness of Tool Change Orders (TCO) and maintenance records. The specialist collaborates with QA and Design Control teams to ensure equipment compliance with regulatory and quality standards, assisting with equipment requirements and validation assessments.

Requirements

  • High School Diploma / GED and 6+ years working in a laboratory environment, or Associates and 4+ years
  • Self-starter, detail-oriented, and effective verbal/written communicator
  • Ethical, responsible, and data-driven decision-making methodology
  • Ability to organize work and judge priorities with guidance
  • Experience creating technical documentation for complex equipment
  • Familiarity with PLM systems (ex. Arena) and document management
  • Knowledge of validation processes and regulatory requirements
  • Experienced with building relationships with engineering staff and vendors
  • Working knowledge of Enterprise Asset Management software (ex. SAP)
  • Experienced with GDP (accurate recordkeeping)
  • Understanding of procurement and inventory control
  • Office software proficiency (Word, Excel) and technical writing capabilities
  • Experience in a medical device regulated environment
  • Able to lift 20 lbs

Responsibilities

  • Create comprehensive documentation for equipment used by R&D teams, including user manuals, technical specifications, and safety guidelines
  • Serve as the go-to resource for engineering staff, providing guidance on tool management processes, documentation, and equipment procurement
  • Organize and maintain equipment files within the PLM system for existing equipment.
  • Ensure accuracy and completeness by revising existing equipment files, including TCO and maintenance records.
  • Collaborate with QA and Design Control to ensure equipment compliance with regulatory and quality standards assisting with equipment requirements and validation assessments
  • Maintain an accurate inventory of tools and equipment, tracking their availability, location, and condition
  • Oversee the equipment tracking system, ensuring timely updates and data integrity
  • Monitor equipment utilization and identify opportunities for optimization or replacement
  • Coordinate equipment training sessions for users, ensuring proper usage and safety protocols
  • Performs or supports execution of small repairs as directed
  • Performs other duties as necessary

Benefits

  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO)
  • And additional employee wellness programs
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