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Computer System Validation Manager Jobs in Linden, NJ

CYNET SYSTEMS

Validation Lead

Raritan, NJ · On-site

$50 - $55/hr

Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and ... Manage end-to-end processes from inventory and assessments to remediations and final dispositions.

Deloitte

System Test and Validation Lead

Morristown, NJ · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

New York, NY · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

New York, NY · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Morristown, NJ · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Linden, NJ

Computer System Validation Manager information

See Linden, NJ salary details

$49.1K

$108.9K

$165.8K

How much do computer system validation manager jobs pay per year?

As of Aug 31, 2026, the average yearly pay for computer system validation manager in Linden, NJ is $108,917.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,000.00 and $136,400.00 per year, depending on experience, location, and employer.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are popular job titles related to Computer System Validation Manager jobs in Linden, NJ?

For Computer System Validation Manager jobs in Linden, NJ, the most frequently searched job titles are:

What cities near Linden, NJ are hiring for Computer System Validation Manager jobs?

Cities near Linden, NJ with the most Computer System Validation Manager job openings:

Computer System Validation Manager jobs near you

Computer System Validation (CSV) Engineer

Piscataway, NJ • On-site

Spadtek Solutions LLC
See more jobs at Spadtek Solutions LLCexternal

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This job post has expired today. Applications are no longer accepted.

Job description

Title : Computer System Validation (CSV) Engineer
Locations: Piscataway, NJ  | Chicago, IL 
Work Arrangement: Onsite
Employment Type: Full-Time
Experience: 5+ Years of CSV Experience in a GxP-Regulated Environment

Job Summary

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, manufacturing and engineering equipment, and enterprise applications.

The CSV Engineer will work closely with Quality, IT, Laboratory, and Manufacturing teams to ensure computerized systems remain validated and compliant with GxP, 21 CFR Part 11, EU Annex 11, and applicable EMA requirements.

This is an onsite position reporting to the Sr. Director of IT. The successful candidate will have strong hands-on experience developing and executing CSV deliverables within a regulated life sciences environment.

Key Responsibilities
  • Plan, author, review, and execute CSV deliverables, including:
    • Validation Plans
    • User Requirements Specifications (URS)
    • Functional Specifications (FS)
    • Design Specifications (DS)
    • IQ/OQ/PQ protocols
    • Traceability Matrices
    • Validation Summary Reports (VSR)
  • Perform CSV activities for:
    • Laboratory instruments such as HPLC, spectrophotometers, and balances
    • Engineering and manufacturing equipment
    • LIMS platforms
    • SAP systems
    • CMMS/calibration systems such as BMRAM
  • Partner with System Owners, QA, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state.
  • Support change control, periodic reviews, and validation lifecycle activities.
  • Conduct computerized system risk assessments and data integrity assessments in alignment with ALCOA+ principles.
  • Support audits, regulatory inspections, CAPA investigations, deviations, and compliance activities related to computerized systems.
  • Collaborate with senior validation leads and subject matter experts to establish and maintain consistent CSV practices across sites.
  • Ensure validation documentation meets applicable regulatory and quality standards.
Required Qualifications
  • Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field, or equivalent laboratory experience within a life sciences environment.
  • Minimum 5 years of Computer System Validation (CSV) experience in a GxP-regulated environment.
  • Strong working knowledge of:
    • 21 CFR Part 11
    • EU Annex 11
    • EMA guidance
    • GxP compliance requirements
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols.
Preferred Qualifications
  • Familiarity with GAMP 5 principles.
  • Experience with risk-based validation methodologies.
  • Exposure to Caliber LIMS.
  • Experience with SAP QM, MM, or PP in a GxP environment.
  • Experience with BMRAM or comparable CMMS/calibration systems.
  • Experience working as a liaison between IT, Quality, Laboratory, and Manufacturing teams.
  • Strong understanding of computerized system lifecycle management and data integrity principles.

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