Data Integrity Specialist

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 located in Titusville, NJ. The Data Integrity Specialist will strengthen site-level data integrity and compliance programs through partnering directly with site stakeholders, SMEs, and vendors to develop frameworks, conduct risk assessments, and support inspection readiness activities within a regulated GMP environment.

Responsibilities of the Data Integrity Specialist:

• Develop and execute Data Integrity (DI) risk assessments across laboratory equipment, systems, and processes.
• Create and maintain Level 3 process flow maps, with an initial focus on laboratory balances and related equipment.
• Facilitate working sessions with site stakeholders, equipment SMEs, and vendors to identify and mitigate DI risks.
• Review existing risk assessments, identify compliance gaps, and recommend improvements.
• Support compliance assessments, configuration management activities, and inspection readiness initiatives.
• Participate in global DI methodology discussions and help implement global requirements at the site level.
• Develop, review, and maintain GxP summary documents, audit trail reviews, periodic reviews, and other DI-related documentation.
• Support training and communication efforts across the organization, including development of DI training curricula.
• Assist with delivery of Data Integrity training programs and workshops for end users and stakeholders.

Qualifications of the Data Integrity Specialist:

• Experience supporting Data Integrity initiatives within a GMP-regulated pharmaceutical environment.
• Background in Computer System Validation (CSV) and Data Integrity preferred.
• Working knowledge of 21 CFR Part 11 and Annex 11 regulatory requirements.
• Strong understanding of Good Documentation Practices (GDP); GDP experience is required.
• Experience conducting data reviews, compliance reviews, or internal audits.
• Proven ability to work directly with stakeholders, SMEs, and cross-functional teams to build compliance frameworks.
• Strong technical writing and documentation skills.
• Experience developing risk assessments, process maps, and controlled quality documentation.
• QC Laboratory and/or Stability Laboratory experience is highly preferred.
• Familiarity with laboratory or stability equipment is a strong plus.
• Bachelor's degree in a scientific, engineering, quality, or related discipline preferred.

Compensation for the Data Integrity Specialist:

• Salary range: $55/hr-75/hr
• Comprehensive benefits package including medical, dental, vision, 401(k), and PTO
• Job term: 15 months, fully on-site

Application Period: This job opens for applications on 09/27/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Data Integrity, Data Integrity Specialist, Computer System Validation (CSV), Data Integrity (DI), Good Documentation Practices (GDP), GMP, Pharmaceutical Manufacturing, Life Sciences, Compliance, Quality Assurance, Quality Documentation, 21 CFR Part 11, Annex 11, Risk Assessments, Process Mapping, Level 3 Process Flows, Audit Trail Reviews, Periodic Reviews, Data Review, Internal Auditing, Inspection Readiness, GxP Documentation, Technical Writing, Regulatory Compliance, Configuration Management, Laboratory Systems, QC Laboratory, Stability Laboratory, Laboratory Equipment Validation, Stakeholder Management, SME Collaboration, Vendor Management, CAPA, Quality Systems, Documentation Control, Training Development, Compliance Assessments, Process Improvement, Validation Lifecycle, Change Control, Computerized Systems, Data Governance, Pharmaceutical Operations, FDA Compliance, Global Quality Standards, Cross-Functional Collaboration, Root Cause Analysis, Quality Management Systems (QMS), Audit Support, Risk Mitigation, Pharmaceutical Compliance, Documentation Review, Validation Documentation, Laboratory Compliance.

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