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Remote Data Entry / Typing jobs

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JOB TITLE:

Remote Data Entry / Typing jobs

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Toronto, ON Canada

JOB DESCRIPTION:

Validation Engineer LOCATION: LaVerne, CA DURATION: 6-12 Months START DATE: April 11^(th) or ASAP Key Skills: Qualification, HVAC, Utilities, Water for Injection (WFI), Compressed Air, Nitrogen, Clean Steam, Clean Rooms, Vial Fillers, Vial Washers, Vial Cappers & Decappers, Control Temperature Units. Summary: We are looking for a Validation Engineer, who can work independently on projects as part of the overall project team. Must be thoroughly familiar with cGMPs and aseptic pharmaceutical manufacturing operations. Must be capable of authoring and executing Commissioning, IQ/OQ/PQ, developing SOPs, final reports and author/adhere to the validation and quality policies/procedures/guidelines. Thoroughly familiar with pharmaceutical unit operations, support systems, process utilities, and environments. Key Responsibilities: - Preparation and execution of Validation life cycle deliverables, URS/CTP/IOQ/PQ/TOPs/Final reports. - Quality review of Validation deliverables generated by project team members. - Experience validating Clean Utilities such as Water for Injection (WFI), Nitrogen, Compressed Air, and Clean Steam; Aseptic Filling Equipment such as Vial Fillers, Vial Washers, Vial Cappers & Decappers, Control Temperature Units. - Reviewing functional, design and testing documentation from Suppliers/Contractors to ensure compliance to cGMP and Good Documentation Practices. - Training Suppliers/Contractors to the agreed C&Q approach and coordinating their activities (as required). - Reviewing Qualification or Test Plans issued by the Suppliers/Contractors for completeness and correctness. - Preparing IQ/OQ procedures and protocols and/or supplementing documentation provided by the Suppliers/Contractors. - Taking part to FAT, SAT, IQ and OQ activities and preparing related reports. - Develop strong working relationships with the internal and external stakeholders and work well within a collaborative team environment. - Punch List and Deviation resolution. - Effectively interfacing and communicating with clients and CQV project team. - Ability to multi-task and adjust priorities to meet aggressive project timelines. Must Have: - Minimum of 3 Years of Experience in cGMP Manufacturing Environments of Pharmaceutical/BioPharma Industries. - Minimum of 4-year bachelor's degree in Life Sciences or Engineering. - Well-developed knowledge of industry standards and requirements (e.g. cGMPs, GAMP, ICH, ISPE baseline guide, ASTM E2500).

Position Details

POSTED:

Nov 26, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S1648497608495522

LOCATION:

Canada

CITY:

Toronto, ON

Job Origin:

OORWIN_ORGANIC_FEED

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Validation Engineer LOCATION: LaVerne, CA DURATION: 6-12 Months START DATE: April 11^(th) or ASAP Key Skills: Qualification, HVAC, Utilities, Water for Injection (WFI), Compressed Air, Nitrogen, Clean Steam, Clean Rooms, Vial Fillers, Vial Washers, Vial Cappers & Decappers, Control Temperature Units. Summary: We are looking for a Validation Engineer, who can work independently on projects as part of the overall project team. Must be thoroughly familiar with cGMPs and aseptic pharmaceutical manufacturing operations. Must be capable of authoring and executing Commissioning, IQ/OQ/PQ, developing SOPs, final reports and author/adhere to the validation and quality policies/procedures/guidelines. Thoroughly familiar with pharmaceutical unit operations, support systems, process utilities, and environments. Key Responsibilities: - Preparation and execution of Validation life cycle deliverables, URS/CTP/IOQ/PQ/TOPs/Final reports. - Quality review of Validation deliverables generated by project team members. - Experience validating Clean Utilities such as Water for Injection (WFI), Nitrogen, Compressed Air, and Clean Steam; Aseptic Filling Equipment such as Vial Fillers, Vial Washers, Vial Cappers & Decappers, Control Temperature Units. - Reviewing functional, design and testing documentation from Suppliers/Contractors to ensure compliance to cGMP and Good Documentation Practices. - Training Suppliers/Contractors to the agreed C&Q approach and coordinating their activities (as required). - Reviewing Qualification or Test Plans issued by the Suppliers/Contractors for completeness and correctness. - Preparing IQ/OQ procedures and protocols and/or supplementing documentation provided by the Suppliers/Contractors. - Taking part to FAT, SAT, IQ and OQ activities and preparing related reports. - Develop strong working relationships with the internal and external stakeholders and work well within a collaborative team environment. - Punch List and Deviation resolution. - Effectively interfacing and communicating with clients and CQV project team. - Ability to multi-task and adjust priorities to meet aggressive project timelines. Must Have: - Minimum of 3 Years of Experience in cGMP Manufacturing Environments of Pharmaceutical/BioPharma Industries. - Minimum of 4-year bachelor's degree in Life Sciences or Engineering. - Well-developed knowledge of industry standards and requirements (e.g. cGMPs, GAMP, ICH, ISPE baseline guide, ASTM E2500).


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