Piper Companies

Data Integrity / CSV Specialist - 175413

Piper Companies • $95K — $115K *
Raritan, NJ 08869In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in scientific, engineering, computer science, or related discipline; equivalent experience considered.
  • 3+ years of experience in pharmaceutical, biotechnology, or other highly regulated industries.
  • Hands-on experience with Data Integrity and Computerized System Validation (CSV) in GMP environments.
  • Strong knowledge 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 with Data Flow Mapping, risk assessments, gap assessments, and Data Integrity remediation activities.
  • Strong understanding of ALCOA+ principles and good documentation practices.

Responsibilities

  • Support Data Integrity assessments and initiatives across various site functions.
  • Lead and conduct Data Process Flow Mapping as a primary focus.
  • Perform Data Integrity gap assessments, risk assessments, and compliance reviews for computerized systems.
  • Conduct periodic onsite reviews to identify data integrity risks and remediation opportunities.
  • Guide SMEs and stakeholders on Data Integrity, CSV, and cGMP compliance requirements.
  • Develop and execute Data Integrity remediation plans, tracking activities through completion.
  • Support audit readiness and serve as the Data Integrity SME during audits and inspections.

Benefits

  • Onsite work schedule promoting collaboration with cross-functional teams.
  • Opportunity to work in a critical role within the highly regulated pharmaceutical industry.
  • Extended duration of the contract, providing job stability through 2027.
  • Engagement with various functions, enhancing professional networking and experience.
  • Possibility to lead critical Data Integrity initiatives and impact compliance practices.
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.

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.

#LI-KP1 #LI-ONSITE

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.
Learn more about Piper Companies
Size
500 employees
Industry
Staffing
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Piper Companies

More Pharmaceuticals & Biotech Jobs

Find similar Data Integrity / CSV Specialist - 175413 jobs:

NationwideRaritan, NJ