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The Spear Group Full-Time Opportunity with Corporate Benefits Position: Process Engineer (Drug Substance - Fermentation & Single Use, min 5 years exp) Location: Carteret, NJ Position Summary: The Spear Group has an exciting career opportunity for an experienced and knowledgeable Proc...

Job Description The Spear Group Full-Time Opportunity with Corporate Benefits Position: Process Engineer (Drug Substance - Fermentation & Single Use - min 5 years) Location: Carteret, NJ Position Summary: The Spear Group has an exciting career opportunity for an experienced and knowledgeable ...

Develops validation / qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports. Commissioning / Qualification Specialist / Specific Commissioning and Validation Support Job Number: 25-04384 Be part of a company that delivers life-cha...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports. Commissioning/Qualification Specialist / Specific Commissioning and Validation support. CSV experience, Draft Qualification/validation documents such as Va...

The ideal candidate will have:BS degree in Engineering / Computer Science or equivalent with 2 years of experience OR Associate degree with at least 4 years of relevant experience Experience in Computer System Validation (CSV), including drafting qualification and validation documents such as Val...

Draft and execute key validation documents including validation plans, user requirements, IQ/OQ/PQ protocols, RTMs, VSRs, and change control documentation. Design and run engineering studies to define and verify critical process parameters prior to system validation. Minimum of 4 years experience...

Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis, execution and approval of IQ, OQ, PQ, and UAT protocols and reports, and perform te...

Write and execute validation documents, including Validation Plans, URS, IQ/OQ/PQ protocols, traceability matrices, and summary reports. Oversee validation of analytical instrumentation and associated computerized systems in accordance with regulatory standards. Maintain compliance with all valid...

Perform hands-on validations and reviews, write quality model validation reports, and provide model approvals. Collaborate with the Project Management Office (PMO) to maintain a viable model validation schedule, coordinate and oversee model validation, and review performed by the model validators...

Write and execute validation documents, including Validation Plans, URS, IQ/OQ/PQ protocols, traceability matrices, and summary reports. Lead or support engineering studies for process parameter definition and verification prior to validation. Minimum of 4 years experience in validation of lab an...

Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis, execution and approval of IQ, OQ, PQ, and UAT protocols and reports, and perform te...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. Su...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. Su...

Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.

The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe ...

Reporting to Model Validation Manager, Model Risk & Validation Team, the Sr Model Validation Specialist plays an active role in the implementation of Model Risk Management framework for the Combined U. Operations of SMFG by performing independent validation and review of Credit Risk and Stress Te...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls. Completes all qualification and validation documentation with accuracy, completeness, and compliance to Company standards. The incumbe...

Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis, execution and approval of IQ, OQ, PQ, and UAT protocols and reports, and perform te...

We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation plannin...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. Su...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. Su...

The Molecular & Validation Manager works closely with senior leadership to drive operational efficiency, maintain regulatory adherence, and promote continuous improvement in molecular diagnostics. Maintain thorough validation documentation and update standard operating procedures (SOPs) as requir...

Support regulatory submissions by preparing validation protocols, reports, and related documentation. Troubleshoot and resolve analytical issues during method development and validation phases. A minimum of 8+ years of experience in analytical testing, method validation, or related roles within t...

The Sr Model Validation Specialist applies numerical, statistical and qualitative knowledge to perform model validation and measures, monitors and reports model risk from model validation perspectives. Reporting to Model Validation Manager, Model Risk & Validation Team, the Sr Model Validation Sp...

We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation plannin...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. Completes all qualification and validation documentation with accuracy, completeness, and compliance to Company standards. The incumbent i...

As a senior member of the team, the TPR Validation Manager is a critical role in the TPRM framework.

We're looking for candidates with great customer service skills to fill our Remote Customer Service role!.This role is entirely remote and offers full-time/Part time hours with flexibility.We are ready to schedule interviews for this week.We're seeking someone who is great with people, building r...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

We're looking for candidates with great customer service skills to fill our Remote Customer Service role!.This role is entirely remote and offers full-time/Part time hours with flexibility.We are ready to schedule interviews for this week.We're seeking someone who is great with people, building r...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

We're looking for candidates with great customer service skills to fill our Remote Customer Service role!.This role is entirely remote and offers full-time/Part time hours with flexibility.We are ready to schedule interviews for this week.We're seeking someone who is great with people, building r...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...

Outlier is the world’s leading expert platform, connecting a network of over 100,000 contributors worldwide to improve AI models by providing expert human feedback.We partner with companies including OpenAI, Meta and Microsoft to enable advanced generative AI models to provide accurate responses ...