Validation Documentation Lead
2 days ago
The Validation Documentation Lead will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols to ensure compliance with internal and regulatory standards.
Key Responsibilities:- Manage validation documentation in automated systems, including documentation control and archiving.
- Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports.
- Collaborate with the CQV and engineering teams to ensure documentation aligns with project milestones.
- Provide necessary documentation in audits and inspections.
- Ensure all documentation control activities comply with FDA cGMP and internal quality standards.
- Bachelor's degree in Life Sciences, Engineering, or related field.
- 8 years of experience in documentation control and quality assurance in pharmaceutical settings.
- Expertise in validation documentation management and quality review processes.
- Strong understanding of regulatory requirements, including FDA and cGMP.
- Excellent attention to detail and organizational skills.
- At least 3 years of experience/knowledge with automated systems, including programming and improving complex systems.
- Familiarity with at least one computer coding language (such as Python, Java, C#, HTML).
- Understanding of version control systems (like GitHub or GitLab).
- Able to independently contribute through development and optimization of automation technologies.
- Able to oversee implementation of automation technologies with third parties through technical support and project management principles.
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Validation Documentation Specialist
5 days ago
New Brunswick, New Jersey, United States Pharmatek Consulting Inc Full timeJob Title: Validation Documentation SpecialistThe Validation Documentation Specialist will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols to ensure compliance with internal and regulatory standards.Key Responsibilities:Manage validation...
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Document Control Lead
3 weeks ago
New Brunswick, New Jersey, United States Pharmatek Consulting Inc Full timeJob DescriptionThe Document Control Lead will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols, ensuring compliance with internal and regulatory standards.Key Responsibilities:Manage validation documentation in automated systems, including...
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Documentation Control Lead
24 hours ago
New Brunswick, New Jersey, United States Verista Full timeJob SummaryVerista is seeking a skilled Documentation Control Lead to join our team. As a key member of our quality assurance team, you will be responsible for managing validation documentation in automated systems, performing quality reviews of IQ/OQ/PQ protocols, and collaborating with cross-functional teams to ensure documentation aligns with project...
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System Validation Lead
4 weeks ago
New Brunswick, New Jersey, United States RIT Solutions, Inc. Full timeSystem Validation LeadRIT Solutions, Inc. is seeking a highly experienced System Validation Lead to join our team. As a key member of our organization, you will be responsible for guiding project teams in the development and implementation of software solutions that meet regulatory requirements.Key Responsibilities:Lead the validation process for computer...
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System Validation Lead
1 week ago
New Brunswick, New Jersey, United States RIT Solutions, Inc. Full timeSystem Validation LeadRIT Solutions, Inc. is seeking a highly experienced System Validation Lead to join our team. As a key member of our organization, you will be responsible for guiding project teams in the development and implementation of software solutions that meet regulatory requirements.Key Responsibilities:Lead the validation process for computer...
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Documentation Control Specialist
3 weeks ago
New Brunswick, New Jersey, United States Pharmatek Consulting Inc Full timeJob Title: Documentation Control LeadThe Documentation Control Lead will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols to ensure compliance with internal and regulatory standards.Key Responsibilities:Manage validation documentation in...
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Documentation Control Specialist
4 days ago
New Brunswick, New Jersey, United States Pharmatek Consulting Inc Full timeJob Title: Documentation Control LeadThe successful candidate will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols, ensuring compliance with internal and regulatory standards.Key Responsibilities:Manage validation documentation in automated...
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Validation Specialist
4 weeks ago
New Brunswick, New Jersey, United States On Target Staffing Full timeValidation EngineerWe're seeking a skilled Validation Engineer to contribute to the success of our dynamic dietary supplement and OTC manufacturing company. As a key member of our team, you'll play a crucial role in validating our manufacturing systems and processes to ensure they meet quality, safety, and regulatory standards.Key Responsibilities:Develop...
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Document Control Specialist
3 weeks ago
New Brunswick, New Jersey, United States Intellectt Inc Full timeJob DescriptionIntellectt Inc is seeking a highly skilled Document Control Specialist to join our team. As a key member of our quality assurance team, you will be responsible for maintaining the lifecycle of validation documents within our automated system.Key Responsibilities:Manage validation documentation in automated systems, including document control...
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Senior Validation Specialist
4 days ago
New Brunswick, New Jersey, United States RIT Solutions, Inc. Full timeJob Title: System Validation LeadRIT Solutions, Inc. is seeking a highly experienced System Validation Lead to join our team.Key Responsibilities:Lead the validation process for computer systems, ensuring compliance with GxP regulations and industry standards.Develop and implement validation strategies, plans, and procedures to ensure the quality and...
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Validation Project Manager
4 weeks ago
New Brunswick, New Jersey, United States PSC Biotech Full timeAbout PSC BiotechPSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.Job SummaryWe are seeking an experienced Validation Project Engineer to join our team. As a key member of our CQV team, you will be...
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Validation Project Manager
4 days ago
New Brunswick, New Jersey, United States PSC Biotech Full timeAbout PSC BiotechPSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.Job SummaryWe are seeking an experienced and motivated Validation Project Engineer to join our team. As a key member of our CQV team, you...
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Validation Project Engineer
5 days ago
New Brunswick, New Jersey, United States PSC Biotech Full timeAbout the RolePSC Biotech is seeking an experienced and motivated Validation Project Engineer to plan, execute, and manage CQV projects, manage vendors, and provide technical review. This role will drive successful project and deliverable completion, adhering to industry standards and regulations.Key ResponsibilitiesDrive project success by assessing...
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Validation Project Manager
1 day ago
New Brunswick, New Jersey, United States PSC Biotech Full timeAbout the RolePSC Biotech is seeking an experienced Validation Project Manager to lead our CQV projects, manage vendors, and provide technical execution review.This role will drive successful project and deliverable completion adhering to industry standards and regulations.Key ResponsibilitiesAssess priorities and project plans, schedule, and budget to...
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Lead CQV Engineer/Analyst
3 days ago
New Brunswick, New Jersey, United States Verista Full timeJob Title: Lead CQV Engineer/AnalystVerista is seeking a highly skilled and experienced Lead CQV Engineer/Analyst to join our team. As a key member of our commissioning and qualification team, you will be responsible for ensuring the validation of production equipment in pharmaceutical environments.Key Responsibilities:Author and execute technical...
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Facilities Utilities Lead
5 days ago
New Brunswick, New Jersey, United States Pharmatek Consulting Inc Full timeJob Title: Facilities Utilities LeadWe are seeking a highly skilled Facilities Utilities Lead to join our team at Pharmatek Consulting Inc. This individual will be responsible for overseeing the qualification of building utilities and environmental systems, ensuring regulatory compliance and traceability to design requirements.Key Responsibilities:Lead CQV...
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Lead CSV Engineer/Analyst
2 weeks ago
New Brunswick, New Jersey, United States Verista Full timeJob Title: Lead CSV Engineer/AnalystVerista is seeking a highly skilled Lead CSV Engineer/Analyst to join our team. As a key member of our automation team, you will be responsible for authoring, editing, and executing technical commissioning, qualification, and validation documentation for standard equipment, systems, and software.Responsibilities:Authoring,...
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Lead CQV Engineer/Analyst
4 weeks ago
New Brunswick, New Jersey, United States Verista Full timeJob OverviewVerista is seeking a highly skilled Lead CQV Engineer/Analyst to join our team. As a key member of our organization, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesDevelop and execute commissioning, qualification, and validation protocols for production equipment.Lead risk...
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Lead CSV Engineer/Analyst
4 weeks ago
New Brunswick, New Jersey, United States Verista Full timeJob OverviewVerista is seeking a highly skilled Lead CSV Engineer/Analyst to join our team. As a key member of our automation and validation team, you will be responsible for authoring, editing, and executing technical commissioning, qualification, and validation documentation for standard equipment, systems, and software.Key Responsibilities:Develop and...
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Quality Lead/Lead Validation Engineer
10 hours ago
New York, New York, United States Verista Full timeJob SummaryVerista is seeking a highly skilled Quality Lead/Lead Validation Engineer to join our team. In this role, you will be responsible for supporting the QISM group at the Client, specifically focused on IT Infrastructure and the Clinical Operations areas.This position will work closely with operational functions, DTE (IT), and other GxP QA groups to...