Equipment Setup Technician - Berkshire Sterile Manufacturing : Job Details

Position Summary 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. Duties and 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

Regulatory Responsibilities

• 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

Supervisory Responsibilities

• N/A

Experience

• 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, 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

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