Equipment Setup Technician 2nd shift

SHARP STERILE MANUFACTURING LLC•Lee, MA

1d•Onsite

About The Position

The Equipment Setup Technician, following Standard Operating Procedures (SOPs), is responsible for the mechanical setup, operation, control and monitoring of all components of BSM’s aseptic filling lines. The successful candidate demonstrates a sense of urgency, contagious optimism and a “can do” attitude. They lead by example and hold themselves and others accountable, while maintaining productive and professional relationships with internal and external departments.

Requirements

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

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
Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable.
Provide guidance in daily operations
Assist employees in compliance of practices