Bachelor's or Master's degree in a scientific, engineering, computer science, or related discipline; equivalent experience may be considered.
3+ years of experience in 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.
Strong analytical and problem-solving skills with the ability to make risk-based quality decisions.
Responsibilities
Support Data Integrity assessments and initiatives across various site functions.
Lead and support Data Process Flow Mapping as a primary focus.
Conduct Data Integrity gap assessments, risk assessments, and compliance reviews for computerized systems.
Perform onsite periodic reviews to identify data integrity risks and remediation opportunities.
Provide guidance to SMEs and stakeholders on Data Integrity, CSV, and cGMP compliance requirements.
Support development and execution of Data Integrity remediation plans and track activities.
Partner with cross-functional teams to ensure Data Integrity and CSV requirements are incorporated into new systems and processes.
Benefits
Opportunity to join a high-visibility Data Integrity and CSV initiative within a major pharmaceutical environment.
Exposure to both strategic Data Integrity programs and hands-on site-level execution.
Direct influence on data quality, compliance, and system integrity through 2027.
Full Job Description
Data Integrity / CSV Specialist
Location: Titusville, NJ
Duration: 15+ months | Through 2027
Schedule: Primarily onsite
Industry: Pharmaceutical / Life Sciences Key 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.
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.
Strong analytical and problem-solving skills with the ability to make risk-based quality decisions.
Excellent written and verbal communication skills with the ability to work effectively with Quality, IT, Engineering, Automation, QC, and business stakeholders.
Why Consider This Opportunity? This is an opportunity to join a high-visibility Data Integrity and CSV initiative within a major pharmaceutical environment, supporting critical quality and compliance activities through 2027. The role provides exposure to both the strategic Data Integrity program and hands-on site-level execution, with the opportunity to directly influence data quality, compliance, and system integrity.
This job opens for applications on 9/24/2026. Applications for this job will be accepted for at least 30 days from the posting date.
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About Piper Companies
Piper Companies is a staffing and recruiting firm based in Conshohocken, Pennsylvania. It provides staffing solutions for a variety of industries, including technology, healthcare, and finance. The company was founded in 2011 and has since grown to become a leading provider of staffing services in the Philadelphia area. Piper Companies is committed to providing high-quality service to its clients and candidates, and has a strong focus on building long-term relationships. The company is also known for its corporate social responsibility initiatives, including support for local charities and community organizations.
