Berkshire Sterile Manufacturing - Lee, MA

posted 18 days ago

Full-time
Lee, MA
251-500 employees
Chemical Manufacturing

About the position

The Equipment Setup Technician is responsible for the mechanical setup, operation, control, and monitoring of all components of Berkshire Sterile Manufacturing's aseptic filling lines. This role requires adherence to Standard Operating Procedures (SOPs) and emphasizes a sense of urgency, optimism, and accountability. The technician will work closely with various departments to ensure efficient filling activities and compliance with manufacturing procedures.

Responsibilities

  • Execute all filling activities in an efficient manner in compliance with all applicable manufacturing procedures.
  • Install appropriate change parts to setup process equipment in the aseptic and non-aseptic areas such as filling machine, capping machine, vial washer, etc.
  • Troubleshoot and repair equipment during aseptic filling operations.
  • Provide real-time status updates of the operation of a line or individual piece of equipment.
  • Train future new team members in the set-up, routine operation and troubleshooting of aseptic fill equipment.
  • Study blueprints, sketches, drawings, specifications and manuals to understand machine setup, operation and troubleshooting.
  • Coordinate with Facilities Department to ensure timely preventative maintenance or request appropriate corrective maintenance on the applicable equipment.
  • Assist the engineering and validation departments with installation, operation and performance qualifications of manufacturing equipment.
  • Write and revise Batch Records, SOPs and notebook studies.
  • Initiate and work on a variety of quality forms including managements of changes, deviations, event reports and corrective and preventative actions.
  • Learn and follow all good manufacturing practices and safety procedures.
  • Other duties as assigned.

Requirements

  • Prior experience setting up and operating automated manufacturing equipment.
  • Demonstrated mechanical knowledge.
  • High school diploma or GED equivalent.

Nice-to-haves

  • Familiarity with formulation, filling and primary packaging and aseptic processing.
  • Experience with Microsoft Office and general computer proficiency.
  • Attention to detail.
  • Technical reading and writing.
  • Mechanical aptitude.
  • Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities.
  • Honesty, integrity, respect and courtesy with leadership and peers.
  • Ability to build collaborative relationships.
  • Strong adherence to verbal instructions.
  • Can resolve routine and complex problems.
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