Data Integrity Specialist: GMP/CSV Compliance Lead

Zachary Piper Solutions; Titusville (NJ); On-site; USD 76,000 - 103,000; Full time

Benefits offered by this job

Medical Insurance

401(k)

PTO

Job summary

Piper Companies is seeking a Data Integrity Specialist to support a leading pharmaceutical organization in Titusville, NJ. The role strengthens site DI programs, partnering with site stakeholders, SMEs, and vendors to develop risk assessments and inspection readiness in a GMP environment.

The specialist will develop DI frameworks, review audits, and contribute to training with robust technical writing and cross-functional collaboration.

Qualifications

• Experience supporting Data Integrity initiatives in GMP environments.
• Background in Computer System Validation (CSV) and Data Integrity preferred.
• Knowledge of 21 CFR Part 11 and Annex 11 requirements.
• Strong GDP understanding and data/documentation skills.
• Experience with data reviews, compliance reviews, or internal audits.
• Ability to build compliance frameworks with stakeholders and cross-functional teams.
• Excellent technical writing and documentation abilities.
• Experience creating risk assessments, process maps, and controlled quality docs.

Responsibilities

• Develop and execute Data Integrity risk assessments across labs and systems.
• Create Level 3 process flow maps for laboratory equipment.
• Lead sessions with stakeholders to identify and mitigate DI risks.
• Review risk assessments for gaps and drive improvements.
• Support compliance assessments, configuration management, and inspection readiness.
• Engage in global DI discussions and implement site-level requirements.
• Prepare GxP documentation, audit trails, reviews, and periodic reports.
• Assist with DI training programs and curricula delivery.

Skills

GxP Compliance

Risk Assessments

Process Mapping

Technical Writing

Stakeholder Management

Audit Support

Regulatory Compliance

Education

Bachelor's degree in a scientific/engineering/quality field

Tools

CSV

Job description

Piper Companies is seeking a Data Integrity Specialist to support a leading pharmaceutical organization in Titusville, NJ. The role strengthens site DI programs, partnering with site stakeholders, SMEs, and vendors to develop risk assessments and inspection readiness in a GMP environment.

The specialist will develop DI frameworks, review audits, and contribute to training with robust technical writing and cross-functional collaboration.