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Computer System Validation Manager Jobs in Linden, NJ

Responsible to support to Computer system validation of Quality control applications. * Review of regulatory inspections observations to perform gap assessment and implementation of corrective ...

... • Support basic Computer System Validation (CSV) activities. Required Skills & Tools: • ... Management System), if applicable. • Experience using Kneat is preferred.

Provide updates to management through established mechanisms. * Actively participate in all phases ... Computer troubleshooting: 6 to 10 years * GXP System Validation/21CFR Part 11: 6 to 10 years

CSV Engineering Lead

New York, NY · On-site

$112K - $147K/yr

Computer system validation at Neko is not only about compliance. It is equally about making our ... Strong grounding in risk management and risk management tooling. * A learn-and-adapt mindset: you ...

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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 Jul 18, 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 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 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 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 job categories do people searching Computer System Validation Manager jobs in Linden, NJ look for? The top searched job categories for Computer System Validation Manager jobs in Linden, NJ 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:
Sr. Data Platform Engineer - Computer System Validator

Sr. Data Platform Engineer - Computer System Validator

Recursion

New York, NY • On-site

$125K - $150K/yr

Other

Posted 20 days ago


Job description

Recursion is a leading, clinical-stage TechBio company decoding biology to industrialize drug discovery. Central to its mission is the Recursion Operating System (OS), a platform built across diverse technologies that continuously expands one of the world's largest proprietary biological, chemical and patient-centric datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale-up to millions of wet lab experiments weekly-and massive computational scale-owning and operating one of the most powerful supercomputers in the world-Recursion is uniting technology, biology, chemistry and patient-centric data to advance the future of medicine.

In this role, you will:

  • Build, scale, and operate in a validated data platform. You will be a member of the platform team responsible for building, operating, and tuning a data platform with petabyte scale data, and maintaining a GxP-compliant data platform for clinical data. These platforms allow our users to discover and query across the breadth of our data at Recursion, which includes a chemistry library of billions of compounds, cellular microscopy images taken in millions of different experimental contexts, and millions of assay results, all supporting Recursion's drug discovery.
  • Engineer Data Integrity and Traceability: You will ensure data flows with integrity in the validated environment by building the automated audit trails and lineage required by 21 CFR Part 11 making our datasets in the clinical datalake queryable and relatable for regulatory questions. Additionally, you'll work with biologists, chemists, and data scientists to build relatability and query-ability into these datasets so they can be used in the future to answer the sorts of questions we haven't even thought of asking yet.
  • Act as a mentor, coach, and sponsor. You will share your technical knowledge and experiences, delivering impact, learning, and growth across teams at Recursion.

The Team You'll Join

  • You will join the Data Lake team that built and maintains our Data Lake/house. The team is responsible for relational and object storage and has the motto: all data flows to the Data Lake. The team solves the problem of making our diverse data discoverable, queryable, and relatable across datasets while we continue to add new data modalities as we grow. This will require collaboration with many different groups including teams building out reports, dashboards, and applications, teams finding and generating the required data for machine learning problems, and teams building and iterating on new data processing pipelines.

Nice to Haves: Experience in a regulated environment (Fintech, Medicine, Nuclear Industry, etc.), Experience with Search (Elasticsearch), Vector/Graph databases, or deep experience scaling within the GCP ecosystem is a significant plus.

Working Location & Compensation:

This is an office-based, hybrid position at either of our US offices located in Salt Lake City, Utah or New York City, New York. Employees are expected to work in the office at least 50% of the time.

At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $142,500 - $220,500. You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package. 

At Recursion, we believe that every employee should be compensated fairly. Based on the skills, experience, and qualifications needed for this role, the estimated annual base salary range is:

  • New York City, Boston, & San Francisco Bay Area(s): $156,750-$211,420
  • Salt Lake City & all other U.S. locations: $142,500-$192,200

In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.

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