System Validation Lead
2 months ago
• 10+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area
• Has working experience in any one or two of the following domains - Clinical Development and Supply Chain, Drug Discovery, MES, QMS, LIMS, Data Integrity Platforms
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
• Application of F DA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 nd Risk Based Approach with the ability to guide the project teams
• Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and requirements and documents them for software development.
• Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix.
• Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and requirements and documents them for software development.
• Should be able to handle and guide multiple GxP projects
• Ability to work with project team to facilitate interaction between Project team and Business Stake holders.
• Ability to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and Tools • Trains the project team on the relevant procedures associated with different SDLC processes and Tools
• Strong in Project Management tools like JIRA
• Manage Project priorities based upon identified risks.
• Performs Periodic Review
• Performs CAPA Management, Deviations Management
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System Validation Lead
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Validation Documentation Lead
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Senior Validation Specialist
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Validation Specialist
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Validation Engineer
1 month ago
New Brunswick, United States On Target Staffing Full timeWe're searching for a dedicated Validation Engineer to join our team at a dynamic dietary supplement and OTC manufacturing company. You'll be instrumental in validating our manufacturing systems and processes to ensure they meet quality, safety, and regulatory standards.Requirements:Bachelor's degree in Engineering, Chemistry, or a related field.Minimum of...
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Validation Engineer
1 month ago
New Brunswick, United States On Target Staffing Full timeWe're searching for a dedicated Validation Engineer to join our team at a dynamic dietary supplement and OTC manufacturing company. You'll be instrumental in validating our manufacturing systems and processes to ensure they meet quality, safety, and regulatory standards.Requirements:Bachelor's degree in Engineering, Chemistry, or a related field.Minimum of...
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Validation Documentation Specialist
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Quality Lead/Lead Validation Engineer
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Validation Project Manager
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Validation Project Manager
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Quality Lead/Lead Validation Engineer
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Validation Project Engineer
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Validation Engineer
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New Brunswick, United States PSC Biotech Full timePSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled...
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Validation Engineer
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New Brunswick, United States PSC Biotech Full timePSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled...
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Senior Systems Engineer Lead
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Computer Systems Validation Specialist
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New Bedford, Massachusetts, United States Lexington Medical, Inc. Full timeAt Lexington Medical, Inc., we are seeking a talented Electromechanical Systems Verification and Validation Engineer to join our team. This role will be responsible for developing high-level verification and validation testing plans for electromechanical systems in collaboration with mechanical, electrical, and software engineers.The ideal candidate will...
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Validation Engineer
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New Brunswick, United States PSC Biotech Full timePSCBiotech provides the life sciences with essential services toensure that health care products are developed manufactured anddistributed to the highest standards in compliance with allapplicable regulatory requirements.Ourgoal is to skyrocket our clients success and you can be a part ofour team s achievements. Employing a global team of...