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Job Details
Novartis
Mechanic - Sr Support Specialist
Job Description
With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry
Purpose:
Ensures the packaging of safe and effective product in an efficient manner. Ensures equipment is installed, set up, and maintained properly. Provide technical training and guidance. Continuously improves production operations by performing any actions required to support departmental goals while adhering to safety and quality guidelines while reducing costs.
Major Accountabilities
• Demonstrates the versatility to perform set up, trouble shoot and maintain entire packaging floors on all formats in the timeframe required to meet department expectations and efficiencies. Example: Tube filling lines as well as bottle filling lines and or foil pack machinery.
• Improves operational effectiveness by studying process methods, making suggestions for improvements, and assisting in the execution of such improvements. (i.e participating in continuous improvement initiatives)
• Execute preventive maintenance (PM)/(work order) task lists and ensures proper documentation to maintain FDA compliant operation.
• Supports packaging operations as required, performs setups, trouble shoots, documents activities according to procedures, provides updates to GAMED system (as necessary), repairs packaging equipment, and performs other duties as required while maintaining operational efficiency andin a timeframe required to meet departmental expectations and efficiencies. (I.e, schedule adherence)
• Disassembles and cleans equipment as needed for efficient and proper line clearance.
• Operates machines by performing all necessary challenges and checks as per filling
Instructions.
• Documents all maintenance, adjustments and repairs in the appropriate log books or documents.
• Assesses equipment condition and makes recommendations for maintenance activities as required to maintain operational efficiencies and performance.
• Assists in Engineering studies, Validation, FAT, Qualifications and provides input to equipment related SOPs.
• Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety policies (i.e. Lock Out/Tag Out), and current Good Manufacturing Practices (cGMPs).
• Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency and volume demands while not sacrificing quality or safety.
• Maintain effective communication between shifts.
• Coordinate with other departments as necessary to maintain efficiency of the lines.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.
• Assists in controlling of spare parts inventory and order as necessary
• Trains mechanical and packaging personnel.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee will be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.
To perform this job successfully, an individual must have satisfactory visual acuity. Visual acuity screenings may be used to screen applicants.
Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected
Purpose:
Ensures the packaging of safe and effective product in an efficient manner. Ensures equipment is installed, set up, and maintained properly. Provide technical training and guidance. Continuously improves production operations by performing any actions required to support departmental goals while adhering to safety and quality guidelines while reducing costs.
Major Accountabilities
• Demonstrates the versatility to perform set up, trouble shoot and maintain entire packaging floors on all formats in the timeframe required to meet department expectations and efficiencies. Example: Tube filling lines as well as bottle filling lines and or foil pack machinery.
• Improves operational effectiveness by studying process methods, making suggestions for improvements, and assisting in the execution of such improvements. (i.e participating in continuous improvement initiatives)
• Execute preventive maintenance (PM)/(work order) task lists and ensures proper documentation to maintain FDA compliant operation.
• Supports packaging operations as required, performs setups, trouble shoots, documents activities according to procedures, provides updates to GAMED system (as necessary), repairs packaging equipment, and performs other duties as required while maintaining operational efficiency andin a timeframe required to meet departmental expectations and efficiencies. (I.e, schedule adherence)
• Disassembles and cleans equipment as needed for efficient and proper line clearance.
• Operates machines by performing all necessary challenges and checks as per filling
Instructions.
• Documents all maintenance, adjustments and repairs in the appropriate log books or documents.
• Assesses equipment condition and makes recommendations for maintenance activities as required to maintain operational efficiencies and performance.
• Assists in Engineering studies, Validation, FAT, Qualifications and provides input to equipment related SOPs.
• Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety policies (i.e. Lock Out/Tag Out), and current Good Manufacturing Practices (cGMPs).
• Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency and volume demands while not sacrificing quality or safety.
• Maintain effective communication between shifts.
• Coordinate with other departments as necessary to maintain efficiency of the lines.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.
• Assists in controlling of spare parts inventory and order as necessary
• Trains mechanical and packaging personnel.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee will be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.
To perform this job successfully, an individual must have satisfactory visual acuity. Visual acuity screenings may be used to screen applicants.
Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected