Electronic Laboratory Notebook (ELN) Implementation & Validation Specialist
VTI Life Sciences (VTI) is seeking forward-thinking, ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to support our teams of industry subject-matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.
We are seeking an experienced professional to support the implementation, validation, and lifecycle management of an Electronic Laboratory Notebook (ELN) platform in a GMP-regulated biotechnology environment. This role will partner with Quality Assurance, Manufacturing, QC, Analytical Development, IT, and business stakeholders to ensure the ELN is implemented and maintained in compliance with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity expectations.
The successful candidate will support system configuration, validation deliverables, testing execution, SOP development, training, and operational readiness activities for GMP use of the ELN platform.
PROJECT OVERVIEW
• Location: Seoul, Korea
• June/July 2026
• Employment Classification: W-2 or Contract
• Length of Project: Approximately 6 months
• Some remote and onsite visits
KEY RESPONSIBILITIES
ELN Implementation Support
• Support implementation and deployment of the ELN platform across GMP and/or GLP laboratory environments
• Collaborate with business stakeholders to gather and document user and functional requirements
• Assist with system configuration, workflow setup, templates, forms, and user roles and permissions
• Coordinate with vendors, IT, QA, and laboratory personnel during project execution
• Support system integration activities across related laboratory and enterprise systems (e.g., LIMS, CDS, ERP, MES)
Computer System Validation (CSV)
• Author, review, and execute validation lifecycle documentation, including:
• Validation Plans
• User Requirements Specifications (URS)
• Functional/Design Specifications
• Risk Assessments
• Traceability Matrices
• IQ/OQ/PQ protocols
• Validation Summary Reports
• Execute and document system testing activities in accordance with GMP and internal quality procedures
• Ensure validation activities follow a risk-based GAMP 5 approach
• Support change control, periodic review, deviation management, and CAPA activities related to validated systems
Regulatory Compliance & Data Integrity
• Ensure compliance with:
• FDA 21 CFR Part 11
• EU Annex 11
• GxP and ALCOA+ data integrity principles
• Assess and verify:
• Audit trails
• Electronic signatures
• Access controls
• Data retention and backup processes
• Security and role-based permissions
Documentation & Training
• * Develop and revise SOPs, work instructions, and training materials
• Conduct end-user training and support user adoption activities
• Maintain validation and system lifecycle documentation in an audit-ready state
REQUIRED QUALIFICATIONS
Education
• Minimum Bachelor’s degree in Life Sciences, Computer Science, Engineering, Information Systems, or a related field.
Experience
• 5–7+ years of experience in:
• Computer System Validation (CSV)
• Laboratory Informatics
• GMP-regulated pharmaceutical or biotech environments
• Hands-on experience implementing or validating ELN systems, LIMS, CDS, or other regulated computerized systems
• Experience authoring and executing validation documentation
• Familiarity with laboratory workflows and regulated documentation practices
Technical & Regulatory Knowledge
• GMP regulations
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Data integrity principles (ALCOA+)
• Risk-based validation methodologies
Preferred Qualifications
• Experience with commercial ELN platforms such as:
• Benchling
• IDBS
• LabWare
• BIOVIA
• Dotmatics
• LabArchives
• Experience supporting GMP QC or Manufacturing laboratories
Key Competencies
• Strong technical writing and documentation skills
• Excellent organizational and project coordination abilities
• Ability to communicate effectively with scientific, QA, and IT teams
• Detail-oriented with strong compliance mindset
• Ability to manage multiple priorities in a fast-paced environment
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation, and Validation Services to the Pharmaceutical, Biotechnology, Biologics, and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, and a stimulating, collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm, and diligence.
As one of the leading global Commissioning, Qualification, and Validation Services organizations, VTI is always seeking innovative, talented, and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time and permanent employees. www.validation.org
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We are seeking an experienced professional to support the implementation, validation, and lifecycle management of an Electronic Laboratory Notebook (ELN) platform in a GMP-regulated biotechnology environment. This role will partner with Quality Assurance, Manufacturing, QC, Analytical Development, IT, and business stakeholders to ensure the ELN is implemented and maintained in compliance with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity expectations.
The successful candidate will support system configuration, validation deliverables, testing execution, SOP development, training, and operational readiness activities for GMP use of the ELN platform.
PROJECT OVERVIEW
• Location: Seoul, Korea
• June/July 2026
• Employment Classification: W-2 or Contract
• Length of Project: Approximately 6 months
• Some remote and onsite visits
KEY RESPONSIBILITIES
ELN Implementation Support
• Support implementation and deployment of the ELN platform across GMP and/or GLP laboratory environments
• Collaborate with business stakeholders to gather and document user and functional requirements
• Assist with system configuration, workflow setup, templates, forms, and user roles and permissions
• Coordinate with vendors, IT, QA, and laboratory personnel during project execution
• Support system integration activities across related laboratory and enterprise systems (e.g., LIMS, CDS, ERP, MES)
Computer System Validation (CSV)
• Author, review, and execute validation lifecycle documentation, including:
• Validation Plans
• User Requirements Specifications (URS)
• Functional/Design Specifications
• Risk Assessments
• Traceability Matrices
• IQ/OQ/PQ protocols
• Validation Summary Reports
• Execute and document system testing activities in accordance with GMP and internal quality procedures
• Ensure validation activities follow a risk-based GAMP 5 approach
• Support change control, periodic review, deviation management, and CAPA activities related to validated systems
Regulatory Compliance & Data Integrity
• Ensure compliance with:
• FDA 21 CFR Part 11
• EU Annex 11
• GxP and ALCOA+ data integrity principles
• Assess and verify:
• Audit trails
• Electronic signatures
• Access controls
• Data retention and backup processes
• Security and role-based permissions
Documentation & Training
• * Develop and revise SOPs, work instructions, and training materials
• Conduct end-user training and support user adoption activities
• Maintain validation and system lifecycle documentation in an audit-ready state
REQUIRED QUALIFICATIONS
Education
• Minimum Bachelor’s degree in Life Sciences, Computer Science, Engineering, Information Systems, or a related field.
Experience
• 5–7+ years of experience in:
• Computer System Validation (CSV)
• Laboratory Informatics
• GMP-regulated pharmaceutical or biotech environments
• Hands-on experience implementing or validating ELN systems, LIMS, CDS, or other regulated computerized systems
• Experience authoring and executing validation documentation
• Familiarity with laboratory workflows and regulated documentation practices
Technical & Regulatory Knowledge
• GMP regulations
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Data integrity principles (ALCOA+)
• Risk-based validation methodologies
Preferred Qualifications
• Experience with commercial ELN platforms such as:
• Benchling
• IDBS
• LabWare
• BIOVIA
• Dotmatics
• LabArchives
• Experience supporting GMP QC or Manufacturing laboratories
Key Competencies
• Strong technical writing and documentation skills
• Excellent organizational and project coordination abilities
• Ability to communicate effectively with scientific, QA, and IT teams
• Detail-oriented with strong compliance mindset
• Ability to manage multiple priorities in a fast-paced environment
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation, and Validation Services to the Pharmaceutical, Biotechnology, Biologics, and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, and a stimulating, collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm, and diligence.
As one of the leading global Commissioning, Qualification, and Validation Services organizations, VTI is always seeking innovative, talented, and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time and permanent employees. www.validation.org
Apply tot his job
Apply To this Job