Job Description
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvment. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
Responsibilities
- Completing Lyophilized (LYO) cabinet operations
- Operating manual, automatic, and semi-automatic packaging equipment
- Initiates and completes set-up, troubleshooting, and minor repairs of various equipment as necessary to complete operations
- Utilizes computer systems to operate equipment where necessary
- Runs equipment for various size containers, stoppers, caps and other packaging components as required. Makes minor adjustments to equipment to clear jams as necessary, and communicates issues and or problems to technicians or supervisors
- Completes all required log sheets, batch records (including, but not limited to two person reviews, sampling and accountability calculations), training rosters and other documentation with adherence to Right First Time (RFT) accountability
- Interfaces with departmental computer systems/databases Q.E., PCL entries, start/end batches, etc.) and timely accurate SAP transactions as necessary
- Conduct in-process testing/monitoring via paper or electronic systems (dose/seal cl1ecks, leak checks, broken glass ct1ecks, standards/challenges, reconstitution, control boards/charts, etc.)
- Sets up and operates steam and dry heat sterilizers including computer interface operations
- Assembles equipment and performs washing and cleaning of components and equipment
- Prepares LYO Cabinets for operations including computer interface operations and manual cleaning
- Operates LYO cabinets and perform loading and unloading
- Coordinates activities required to manage inventory of supplies, components, and equipment to meet production schedules
- Ensures materials are organized, stored, segregated, and staged for production operations
- Sets up, operates and troubleshoots packaging equipment including making minor repairs as necessary
_Equipment_
- Steam sterilization equipment
- Thaw baths
- Lyophilization cabinets
- Inspection, labeling, packaging and material handling tools and equipment associated with packaging
_Education Requirements:_
- High School Diploma or equivalent
_Required Experience and Skills:_
- Successful completion of SPO Operator - Level 2 Aptitude test
