Position Summary | Senior Operations Engineering 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 operations. 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. The Senior designation includes the additional responsibility of training Operation Engineers and Operators on new size / change parts as well as process improvements in filling operations. |
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
- Contribute to continuous improvement efforts by providing input on fill operation efficacy.
- 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
- Review 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
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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
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Supervisory Responsibilities | |
Experience | - Prior experience setting up and operating automated manufacturing equipment
- Demonstrated mechanical knowledge
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Education | - High school diploma or GED equivalent
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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 proficiency
- 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
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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
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