Validation Consultant

Position : Validation Consultant

Location : New Jersey

Experience : 8+ years

Type : 12+ months

Overview :

We are seeking an experienced Validation Consultant to support Patient Safety, Commercial, and Medical Affairs projects. The role focuses on continuous improvement initiatives, ensuring compliance with regulatory standards, and delivering high-quality validation documentation.

Primary Responsibilities :

Ensure compliance with methodologies, SOPs, and the use of relevant tools.

Develop software validation deliverables and manage review and approval lifecycles.

Verify that project validation deliverables are complete and consistent with GxP.

Record project-related issues and deviations according to SOPs.

Assist in drafting, reviewing, and updating procedures and templates.

Support resolution of Computerized System Validation compliance issues.

Create and manage change controls.

Additional Responsibilities :

Maintain timely, clear, and effective communication with relevant stakeholders.

Ensure adherence to project timelines and proactively communicate potential issues.

Qualifications :

8+ years experience in the Life Sciences industry, working in IT or Quality with oversight of CSV.

Strong knowledge of applicable regulations and guidelines (GxP, SOX, GDPR, etc.).

Experience designing processes and procedures.

Proficient with the latest versions of MS Office.

Experience with Veeva or other systems like QualityDocs, QMS, etc.

Strong autonomy, critical thinking, attention to detail, and documentation skills.

Excellent communication and influence across multiple organizational levels.

Understanding of industry landscape and global regulatory requirements.

Fluent in English (written and verbal).

Education & Certification :

Bachelor's degree in Information Engineering, Bioengineering, or a related field.

Working Conditions :

Prolonged periods of sitting or standing at a desk and working on a computer in a controlled office or home office environment.

Operate standard office equipment such as calculators, scanners, or printers.

Frequent communication with stakeholders via phone, email, or instant messaging.

Travel to client sites as required.

Reasonable accommodations may be made for individuals with disabilities.