Data Integrity / CSV Specialist

Piper Companies; Titusville (NJ); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

Piper Companies seeks a Data Integrity / CSV Specialist in Titusville, NJ, to support Quality and Compliance initiatives. The role blends strategic oversight with hands-on activities focused on data integrity, laboratory and operational system assessments, and remediation tracking.

The ideal candidate has 3+ years in a regulated pharma setting, strong knowledge of 21 CFR 11 and EU Annex 11, and will work onsite with cross-functional teams through 2027.

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.

Responsabilités

• 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.

Connaissances

Data Integrity

CSV

Risk Assessment

GxP Compliance

21 CFR 11

ALCOA+

Documentation Practices

Formation

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

Description du poste

Location: Titusville, NJ

Duration: 15+ months | Through 2027

Schedule: Primarily onsite

Industry: Pharmaceutical / Life Sciences

About The Opportunity

Our client, a leading global pharmaceutical organization, is seeking a Data Integrity / Computerized System Validation (CSV) Specialist to support Quality and Compliance initiatives at their Titusville, NJ site. This role offers a strong blend of strategic and hands-on responsibilities, with a primary focus on Data Integrity, computerized systems, risk assessments, and data process flow mapping. The ideal candidate will be comfortable working directly with site teams and walking through laboratory and operational environments to assess systems, identify risks, and support remediation activities. This position will complement an existing Data Integrity lead whose primary focus is documentation, with this role providing stronger CSV, systems, and technical Data Integrity expertise.

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.