Senior CSV Compliance Specialist

Insight Global; Spring House (PA); Hybrid; USD 103,000 - 131,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HSA, FSA, DCFSA options

401k with employer matching

Paid sick leave / PTO as provided by/法

Job summary

Insight Global is seeking a Senior Computer Systems Compliance Specialist for a hybrid role in Spring House, PA. This 3-month extending contract offers a competitive hourly rate and comprehensive benefits starting day one.

The project focuses on GxP computer systems, CSV, data integrity, and regulatory compliance, with cross-functional collaboration across North America and Europe. Responsibilities include independent compliance health checks, risk-based remediation planning, and concise

Qualifications

• 8+ years in pharmaceutical GxP, CSV, or quality compliance.
• Independent reviews of GxP computerized systems and validation docs.
• Ability to identify risks, gaps, and remediation opportunities.

Responsibilities

• Compliance Assessments & System Reviews (60%): conduct independent reviews of GxP computerized systems and supporting validation documentation.
• Assess system compliance against CSV requirements and GxP regulations.
• Evaluate intended use, classification, validation strategy, and ongoing compliance.
• Review requirements traceability, testing evidence, change control, and lifecycle docs.
• Assess electronic records and electronic signature controls; evaluate data integrity controls.
• Review supplier management controls, periodic reviews, and lifecycle processes.
• Determine fitness-for-use of systems for regulated processes.
• Stakeholder Engagement (20%): conduct interviews with system owners, validate observations, and maintain strong relationships.
• Reporting & Recommendations (20%): document observations, risks, and remediation opportunities; deliver executive-level reports.

Skills

Compliance assessments

Gap assessments

Periodic reviews

Audits (computerized)

CSV

Data Integrity

Electronic Records & Signatures

Risk-based validation

Lifecycle controls

26 CFR Part 11 knowledge

Tools

ELN

CDS

MES

Job description

Senior Computer Systems Compliance Specialist - Job Opportunity

Location: Hybrid in Spring House, PA

Hiring Model: 3 Month Extending Contract (Budget for 3 Months but potential for extensions)

Shift: 1st Shift (M-F)

Compensation: $75/hr to $95/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Required Skills & Experience

8+ years of experience in pharmaceutical GxP, Computer System Validation (CSV), or quality compliance environments.

Hands-on experience performing:

• Compliance assessments
• Gap assessments
• Periodic reviews
• Internal or external audits of computerized systems

Strong knowledge of:

• Computer System Validation (CSV)
• Data Integrity principles
• Electronic Records and Electronic Signatures
• Risk-based validation methodologies
• Computerized system lifecycle controls

Demonstrated ability to independently evaluate validation evidence and system compliance.

Experience identifying compliance gaps, assessing risk, and developing remediation strategies.

Strong written, verbal, and executive-level communication skills.

Nice to Have Skills & Experience

Experience supporting laboratory and manufacturing systems.

Familiarity with regulated platforms such as:

• Electronic Laboratory Notebooks (ELN)
• Chromatography Data Systems (CDS)
• Manufacturing Execution Systems (MES)

Knowledge of:

• 21 CFR Part 11
• EU GMP Annex 11
• GAMP 5
• ALCOA+ Data Integrity principles

Prior regulatory inspection support experience.

Experience working with global cross-functional teams across North America and Europe.

Job Description

Project Overview

This role supports system owners responsible for a portfolio of GxP computerized systems. The consultant will perform an independent compliance health check to assess current-state compliance, identify risks and gaps, and recommend improvements across regulated systems.

Key Responsibilities

Compliance Assessments & System Reviews (60%)

• Conduct independent reviews of GxP computerized systems and supporting validation documentation.
• Assess system compliance against applicable CSV requirements and GxP regulations.
• Evaluate intended use, GxP classification, validation strategy, and ongoing system compliance.
• Review requirements traceability, testing evidence, change control records, and lifecycle documentation.
• Assess electronic records and electronic signature controls.
• Evaluate data integrity controls and compliance with applicable regulatory expectations.
• Review supplier management controls, periodic reviews, and operational lifecycle processes.
• Determine whether systems remain fit for intended use and support regulated business processes.

Stakeholder Engagement (20%)

• Conduct interviews and walkthroughs with system owners and key stakeholders.
• Validate observations and findings through collaborative discussions.
• Challenge current-state practices constructively while maintaining strong stakeholder relationships.

Reporting & Recommendations (20%)

• Document compliance observations, risks, and improvement opportunities.
• Differentiate documentation deficiencies from substantive control weaknesses.
• Perform risk-based prioritization of findings.
• Develop clear, practical remediation recommendations.
• Deliver concise executive-level assessment reports and presentations.