CSV and Data Integrity Consultant

Job Overview

We are seeking an experienced Computer System Validation (CSV) and Data Integrity Consultant to support laboratory system validation, Data Integrity assessments, and remediation within a cGMP-regulated environment. The consultant will evaluate laboratory instruments, computerized systems, software applications, and associated processes; identify compliance gaps; recommend practical remediation; and prepare system lifecycle documentation.

This role will be onsite, open to W2 employees only, and will require experience with computerized laboratory systems and the ability to work independently with laboratory personnel, Quality Assurance, Validation, Information Technology, Engineering, Operations, and system owners.

Responsibilities

• Perform Data Integrity, gap, and 21 CFR Part 11 assessments of laboratory equipment, instruments, computerized systems, and associated processes in accordance with approved plans and procedures.
• Document system inventories, functionality, configurations, data flows, user roles, and technical and procedural controls.
• Evaluate electronic records and electronic signatures (ERES), ALCOA principles, and applicable cGMP requirements throughout the data lifecycle, from creation and processing through review, reporting, retention, archival, and retrieval.
• Review user access, audit trails, logical security, password controls, backup and recovery, data retention, and system time synchronization.
• Identify and document compliance gaps and risks, assess validation impacts, develop remediation recommendations and action plans, and support their execution.
• Author and review CSV lifecycle documentation, including qualification protocols, validation reports, Data Integrity assessment reports, and future-state design and configuration specifications.
• Support or execute installation, operational, and performance qualification (IQ/OQ/PQ) protocols for computerized laboratory systems and QC instrumentation.
• Review laboratory instrument and equipment standard operating procedures and system administration procedures; support approval activities as assigned.
• Participate in laboratory walkthroughs, stakeholder interviews, peer reviews, comment resolution, and project meetings.
• Track deliverables, quality objectives, and project milestones; communicate status, findings, risks, and recommendations to project leadership and client stakeholders.

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, Biotechnology, Chemistry, Microbiology, or a related discipline.
• Minimum five years of experience supporting pharmaceutical, biotechnology, medical device, biologics, or other GxP-regulated organizations.
• Direct experience with Data Integrity assessments or remediation, Part 11 assessments, periodic reviews, and/or CSV activities in a regulated environment.
• Experience evaluating computerized laboratory systems and laboratory instrument software.
• Strong understanding of cGMP, Good Documentation Practices (GDP), Data Integrity principles, CSV, and risk-based compliance methodologies; working knowledge of Good Laboratory Practices (GLP), where applicable.
• Strong technical writing skills and the ability to document findings and prepare clear, defensible client-facing deliverables.
• Ability to facilitate discussions across laboratory, Quality Assurance, Validation, Information Technology, and Operations teams.
• Ability to work independently, manage multiple assignments, and meet quality and project timelines in a fast-paced environment.
• Working knowledge of Microsoft Office applications; strong communication, organization, attention to detail, and professional judgment.
• Commitment to the company Code of Conduct, policies, and regulatory standards.

Preferred Qualifications

• Experience developing or reviewing functional, design, and configuration specifications and other computerized system lifecycle documentation.
• Familiarity with GAMP 5 principles and risk-based computerized system compliance approaches.
• Experience with electronic document management systems such as Veeva.
• Previous consulting experience supporting multiple projects or clients.
• Desired Laboratory Systems Experience
• Experience supporting, assessing, validating, configuring, or maintaining one or more of the following in a GxP-regulated environment is highly desirable:
• PCR and molecular biology platforms.
• Spectroscopy, spectrophotometry, and mass spectrometry systems.
• Automated cell analysis or cell counting systems.
• Analytical instruments generating electronic records and associated instrument control or data acquisition software.

In order to be considered, please answer the following questions:

• How many years of experience do you have performing laboratory Data Integrity assessments in a GMP/GLP-regulated environment?
• How many years of experience do you have assessing computerized systems for compliance with 21 CFR Part 11?
• How many years of CSV experience do you?

Pay: $120,000.00 - $155,000.00 per year

Application Question(s):

• In order to be considered, please answer the following question:

How many years of experience do you have performing laboratory Data Integrity assessments in a GMP/GLP-regulated environment?

• In order to be considered, please answer the following question:

How many years of hands-on experience do you have assessing computerized systems for compliance with 21 CFR Part 11?

• In order to be considered, please answer the following question:

How many years of CSV experience do you have?

Experience:

• pharmaceutical: 5 years (Required)
• CSV: 2 years (Preferred)
• Data Integrity: 2 years (Preferred)

Work Location: In person

Salary : $120,000 - $155,000