TEMP Manufacturing Tech Il - Contract

Title: Manufacturing Tech
Location: Burlington, MA 01803
Duration: 06 Months
Shift: 1st shift - 7.30 am to 4 pm, M-F
Pay rate: $22.38/hr.

Vertical Description:
POSITION OVERVIEW:
(An Overview of the Department & Summary of the Role)

• You will be responsible for the following:
• Perform kitting operations (measure out components or raw materials)
• Ability to perform activities under a microscope
• Prepare components and build device assemblies
• Prepare bulk drug formulations
• Perform filing, capping, and crimping operations
• Perform packaging and labeling operations
• Perform sampling
• Perform visual inspections
• Perform documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)
• Perform all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality management system (QMS) medical device good manufacturing practices (GMP) requirements.
• Additional tasks as required
• Maintain proper cleanroom environment (including gowning, room cleaning, and supplies)
• Follow, execute, and adhere to documentation in accordance with cGMP, QMS, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), batch records (BRs), device history records (DHRs), and engineering batches.
• Perform basic calculation and data entry
• Ability to assemble, disassemble, and clean process equipment
• Ability to clean, etch, passivate, assemble, and inspect components
• Process and assemble components in accordance with documented specifications and procedures
• Prepare bulk drug formulation operations
• Perform filling, capping and crimping operations
• Perform packaging and labeling operations
• Perform in-process inspection of assemblies and finished products in accordance with specification criteria
• Organize and clean the work areas
• Ability to perform validation and qualification activities (IQ/OQ/PQ/PV)

• 2-4 years of related experience in the medical device, pharmaceutical, and/or biotechnology industries, or a AA with less than 1 year of experience
• It is highly desirable to have experience working in and maintaining a cleanroom in accordance with GDP and cGMPs standards.