Data Integrity & CSV Specialist – Onsite Lab Systems Expert

Zachary Piper Solutions; Raritan (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Zachary Piper Solutions seeks a Data Integrity / CSV Specialist for a Titusville, NJ site within a global pharmaceutical organization. The role blends strategic and hands-on work to ensure data integrity, CSV compliance, and risk assessments across laboratories and manufacturing environments.

You will lead data process flow mapping, support remediation activities, and serve as a subject matter expert during audits and inspections, collaborating with Quality, IT, Engineering and QC to embed data

Qualifications

• Bachelor's or Master's degree in a scientific, engineering, computer science, or related discipline; equivalent experience may be considered.
• 3+ years of experience within the pharmaceutical, biotechnology, or other highly regulated industry.
• Hands-on experience with Data Integrity and Computerized System Validation (CSV) in a GMP environment.
• Strong understanding of 21 CFR Part 11, 21 CFR Parts 210/211, GAMP 5, and Data Integrity principles.
• Required: Knowledge and practical experience with EU GMP Annex 11.
• Experience performing Data Flow Mapping, risk assessments, gap assessments, and/or Data Integrity remediation activities.
• Experience assessing computerized systems, laboratory systems, manufacturing systems, or related equipment for Data Integrity compliance.
• Strong understanding of ALCOA+ principles and good documentation practices.
• Ability to work onsite with cross-functional teams and confidently walk through laboratory and operational environments to understand processes, systems, and data flows.

Responsibilities

• Support Data Integrity assessments and initiatives across laboratory, quality, engineering, automation, IT, and other site functions.
• Lead and support Data Process Flow Mapping, initially serving as a primary area of focus for the engagement.
• Conduct Data Integrity gap assessments, risk assessments, and compliance reviews for computerized systems and equipment.
• Perform onsite periodic reviews to identify data integrity risks, vulnerabilities, and opportunities for remediation.
• Provide guidance to SMEs and cross-functional stakeholders on Data Integrity, CSV, and cGMP compliance requirements.
• Support development and execution of Data Integrity remediation plans and track activities through completion.
• Perform and support Data Quality Reviews to identify potential data integrity concerns and ensure appropriate controls are in place.
• Partner with Quality, Engineering, Automation, QC, IT, and other functions to ensure Data Integrity and CSV requirements are incorporated into new systems, equipment, and processes.
• Provide CSV and Data Integrity guidance during system implementations, changes, and other project activities.
• Support audit and inspection readiness and serve as a Data Integrity SME during internal and external audits or regulatory inspections.
• Maintain current knowledge of applicable regulations, industry guidance, and best practices related to CSV and Data Integrity.

Skills

Data integrity

Analytical thinking

Communication

Risk assessment

Education

Bachelor's or Master's in science/engineering/computer science

Tools

CSV systems

GxP systems

21 CFR 11

Job description

Zachary Piper Solutions seeks a Data Integrity / CSV Specialist for a Titusville, NJ site within a global pharmaceutical organization. The role blends strategic and hands-on work to ensure data integrity, CSV compliance, and risk assessments across laboratories and manufacturing environments.

You will lead data process flow mapping, support remediation activities, and serve as a subject matter expert during audits and inspections, collaborating with Quality, IT, Engineering and QC to embed data