Data Integrity Specialist

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

Benefits offered by this job

Medical benefits

Dental & vision insurance

Retirement plans

15 month contract

Job summary

Piper Companies is seeking a Data Integrity Specialist to support a leading pharmaceutical organization in Titusville, NJ. The role focuses on building data integrity frameworks, enabling stakeholder collaboration, and ensuring GMP/GxP compliance across a laboratory environment.

Responsibilities include risk assessments, process mapping, and inspection readiness activities, with a strong emphasis on 21 CFR Part 11, Annex 11, and GDP practices.

Qualifications

• Experience supporting Data Integrity programs within GMP-regulated environments.
• Background in CSV and familiarity with laboratory computerized systems.

Responsibilities

• Develop and execute DI risk assessments for lab systems and processes.
• Create Level 3 process maps and run sessions with SMEs, vendors, and site stakeholders.
• Review risk assessments, audit trails, and quality records for gaps and improvements.
• Support configuration management for lab equipment and computerized systems.
• Collaborate to implement DI methodologies and assist in training.

Skills

DI programs experience

CSV background

21 CFR Part 11 knowledge

Annex 11 familiarity

GDP awareness

GxP compliance

Audit trails review

Tools

Computerized systems

Job description

Piper Companies is seeking a Data Integrity Specialist to support a leading pharmaceutical organization in developing and implementing site-level data integrity initiatives within a laboratory environment in Titusville, NJ. The Data Integrity Specialist will play a critical role in building data integrity frameworks, facilitating stakeholder collaboration, conducting risk assessments, and ensuring compliance with regulatory and quality standards.

Responsibilities of the Data Integrity Specialist:

• Develop and execute Data Integrity (DI) risk assessments for laboratory systems, equipment, and processes.
• Create Level 3 process flow maps and facilitate working sessions with SMEs, vendors, and site stakeholders to identify and mitigate DI risks.
• Review existing risk assessments, compliance documentation, audit trails, periodic reviews, and other GxP-related records to identify gaps and improvement opportunities.
• Support configuration management activities for laboratory equipment and computerized systems while assisting with inspection readiness initiatives.
• Collaborate with teams to implement DI methodologies, communicate requirements, and support training initiatives across the organization.

Qualifications of the Data Integrity Specialist:

• Experience supporting Data Integrity programs within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Background in Computer System Validation (CSV) and familiarity with computerized systems used in laboratory settings.
• Working knowledge of 21 CFR Part 11, Annex 11, Good Documentation Practices (GDP), and GxP requirements.
• Experience reviewing technical documentation, audit trails, quality records, and compliance-related documentation.
• QC Laboratory, Stability Laboratory, internal auditing, or laboratory equipment experience is strongly preferred.

Compensation for the Data Integrity Specialist includes:

• Pay Range: $55-$75 per hour (depending on experience)
• Comprehensive benefits package including medical, dental, vision, and retirement plans
• 15 month contract position

This job opens for applications on 09/23/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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