Sr. Validation Lead

OnShore Technology Group; Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Job summary

OnShore Technology Group in Chicago, IL, seeks a Sr. Validation Lead to oversee CSV activities for designated computerized system implementations in GMP/GLP/GCP environments.

You will develop and review validation test protocols, coordinate with SMEs, and ensure all deliverables align with FDA 21 CFR Part 11, ISPE GAMP 5, and related regulations. The ideal candidate has 10+ years in software quality assurance within life sciences, strong leadership, and proven ability to manage multiple CSV

Qualifications

• Education: B.S. or equivalent in computer science, engineering, life sciences, or related field.
• ASQ CSQE Certification or equivalent preferred.

Responsibilities

• Lead and coordinate multiple CSV projects.
• Develop / review validation test protocols using automated tools.
• Coordinate with SMEs and other departments.
• Ensure validation deliverables comply with internal guidelines and procedures.
• Create and track validation project plans.
• Provide regulatory guidance on CSV principles to the team.

Education

B.S. or equivalent in computer science, engineering, life sciences, or related field

ASQ CSQE Certification or equivalent preferred

Job description

For over 15 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.

OnShore’s leading innovation is ValidationMaster™, the first Enterprise Validation Management System (EVMS) of its kind to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.

The Sr. Validation Lead is primarily responsible for oversight of V&V activities for designated computerized system implementation projects. This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts for applications used in GMP, GLP and/or GCP processes ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs.

ROLES & RESPONSIBILITIES

• Ability to lead and coordinate multiple CSV projects
• Develop / review validation test protocols as required using automated technology tools
• Coordinate / communicate with other departments, SMEs
• Ensure that all validation deliverables are prepared in accordance with internal guidelines, policies and procedures
• Create, track and manage all validation project plans
• Provide regulatory guidance on principles of CSV to the expanded team

EDUCATION & CERTIFICATION

• B.S. or equivalent in computer science, engineering, life sciences, or related field
• Minimum 10 years of experience in software quality assurance in the life sciences industry in a leadership role
• ASQ CSQE Certification or equivalent preferred
• Practical working knowledge of software development and implementation methodologies
• Experience with the validation of Enterprise Resource Planning (ERP) systems is preferred.
• Strong oral and written communication skills in English.
• Excellent interpersonal skills.
• Advanced skills at team management, organization, and communication of priorities and listening
• Practical experience in conducting and supporting CSV audits and inspections.
• Advanced proficiency in the use of Microsoft Office desktop applications

REGULATORY KNOWLEDGE REQUIREMENTS

• U.S. FDA Validation Guidance Document
• 21 CFR Part 11 Electronic Records; Electronic Signature Final Rule
• U.S. FDA Data Integrity Guidance
• NIST Cybersecurity Framework
• 21 CFR Part 210/211 cGMP
• EUDRALEX Annex 11 Rules Governing Medicinal Products in the EU, Volume 4