Validation Engineer,packaging - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Roles&Responsibilities:
Pack Bay 3 will be repurposed to be a dedicated line for the packaging of autoinjector devices for client WCS-081. The new packaging line will be utilizing equipment from the existing line as well as bringing in new equipment. The existing equipment that will be modified include the Dividella Cartoner, Pester Case Packer, Pester Palletizer, Systech Serialization System, and SCADA system. The cartoner, case packer, and palletizer will need to be deactivated prior to making the modifications. The new equipment includes an ATS Tray Unloader and Fuji Seal Labeler. The original equipment that is not being used will need to be deactivated and removed from the room. This equipment includes two Concep Assembly Machines, a Weiler Labeler, a Concep Tray Unloader, a Concep Cartridge Reclaim Machine, a conveyor system, and a Tamper Evident Labeler. Due to the mixture of machines, there will be a mixture of responsibilities for the validation activities.
Requirements:
1.Validation Support
Support all requested validation deliverables for the project described in the project description section of this document for the duration of the purchase agreement.
i.Develop Validation Plan to reference Resilience owned validation activities.
ii.Specification review and facilitate the document control of thesespecifications with other project personnel.
iii.Support client validation by reviewing documents and assisting in execution of FAT and SAT protocols for new equipment.
iv.Protocol drafting, facilitating review cycle and facilitatedocument control with project personnel to approve for execution. Support the execution of all protocols. This includes section review,discrepancies if any occur and summary reports.
v.Support all engineering runs on the project.
This is required for thefollowing protocols:
1.Deactivation protocols for the two assembly machines, labeler, tray unloader, conveyor system, cartridge reclaim machine, cartridge cleaning machine, cartoner, case packer, tamper evident labeler, and palletizer.
2.Two (2) SAT protocols for Resilience specific requirements not covered in the client SAT for the new Tray Unloader, Labeler, and Checkweigher.
3.Systech and Client Addendums for new product classes and recipes.
4.SCADA IOQ addendum for modifications
5.SAT and IOQ addendum for Cartoner modifications.
6.SAT and IOQ addendum for Case Packer modifications.
7.SAT and IOQ addendum for Palletizer modifications.
8.PQ protocol for the entire line integration.
9.PV protocol for a 3X PV of the entire line.
Pack Bay 3 will be repurposed to be a dedicated line for the packaging of autoinjector devices for client WCS-081. The new packaging line will be utilizing equipment from the existing line as well as bringing in new equipment. The existing equipment that will be modified include the Dividella Cartoner, Pester Case Packer, Pester Palletizer, Systech Serialization System, and SCADA system. The cartoner, case packer, and palletizer will need to be deactivated prior to making the modifications. The new equipment includes an ATS Tray Unloader and Fuji Seal Labeler. The original equipment that is not being used will need to be deactivated and removed from the room. This equipment includes two Concep Assembly Machines, a Weiler Labeler, a Concep Tray Unloader, a Concep Cartridge Reclaim Machine, a conveyor system, and a Tamper Evident Labeler. Due to the mixture of machines, there will be a mixture of responsibilities for the validation activities.
Requirements:
1.Validation Support
Support all requested validation deliverables for the project described in the project description section of this document for the duration of the purchase agreement.
i.Develop Validation Plan to reference Resilience owned validation activities.
ii.Specification review and facilitate the document control of thesespecifications with other project personnel.
iii.Support client validation by reviewing documents and assisting in execution of FAT and SAT protocols for new equipment.
iv.Protocol drafting, facilitating review cycle and facilitatedocument control with project personnel to approve for execution. Support the execution of all protocols. This includes section review,discrepancies if any occur and summary reports.
v.Support all engineering runs on the project.
This is required for thefollowing protocols:
1.Deactivation protocols for the two assembly machines, labeler, tray unloader, conveyor system, cartridge reclaim machine, cartridge cleaning machine, cartoner, case packer, tamper evident labeler, and palletizer.
2.Two (2) SAT protocols for Resilience specific requirements not covered in the client SAT for the new Tray Unloader, Labeler, and Checkweigher.
3.Systech and Client Addendums for new product classes and recipes.
4.SCADA IOQ addendum for modifications
5.SAT and IOQ addendum for Cartoner modifications.
6.SAT and IOQ addendum for Case Packer modifications.
7.SAT and IOQ addendum for Palletizer modifications.
8.PQ protocol for the entire line integration.
9.PV protocol for a 3X PV of the entire line.
Source : Katalyst Healthcares & Life Sciences