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Equipment Maintenance Specialist

1 month ago

Lee, Massachusetts, United States BERKSHIRE STERILE MANUFACTURING LLC Full time
{"Job Description": "Job Title: Equipment Setup Technician

Berkshire Sterile Manufacturing LLC is seeking a skilled and detail-oriented Equipment Setup Technician to join our team. In this role, you will be responsible for setting up, operating, and maintaining our aseptic filling lines.

Key Responsibilities:

  • Set up and operate aseptic filling lines, following Standard Operating Procedures (SOPs) and ensuring compliance with all applicable regulations.
  • Install and maintain change parts and equipment, including filling machines, capping machines, and vial washers.
  • 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 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 the Facilities Department to ensure timely preventative maintenance or request appropriate corrective maintenance on 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 management of changes, deviations, event reports, and corrective and preventative actions.
  • Learn and follow all good manufacturing practices and safety procedures.
  • Other duties as assigned.

Supervisory Responsibilities:

  • N/A

Requirements:

  • Prior experience setting up and operating automated manufacturing equipment.
  • Demonstrated mechanical knowledge.

Education:

  • High school diploma or GED equivalent.

Knowledge, Skills & Abilities:

  • 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.
  • Able to follow rules and regulations.
  • Mechanical aptitude.
  • Resilient, able to 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.

Physical Requirements:

  • Ability to meet gowning requirements.
  • Visual acuity.
  • Fine and gross motor skills to manipulate tools and equipment.
  • Ability to remain stationary for continuous prolonged periods of time.
  • Able to occasionally lift 30-50 lbs.
  • Able to wear PPE.
  • Use of standard office equipment with or without reasonable accommodation.
"}