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Computer System Validation Jobs in Bridgewater, NJ

Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment. In this role, you ...

Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment. In this role, you ...

Understanding of computer system validation. Education and Experience: * Bachelor's degree in computer engineering or MIS discipline or commensurate experience. * Minimum 7 years of hands on ...

Jr. QA Tester

Newark, NJ · On-site

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

Validation Engineer

New York, NY · On-site

$70K - $80K/yr

Review system requirements, design specifications, and user stories to ensure they are testable and ... Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field (or ...

Field Computer Specialist

New York, NY · On-site

$5.3K - $5.8K/mo

The position requires a valid driver's license with a clean driving record. A company-provided van ... Security camera systems, DVR/NVRs, coax and IP, including wiring and camera installation ...

Thorough knowledge of and competence in IT processes, including but not limited to deviations, investigations, CAPA management, SLC, computer system validation, and change management. * Must have ...

Perform CSA/CSV for lab systems (LIMS, Empower, Chromeleon) * Develop validation docs: URS, risk assessments, protocols, reports * Ensure compliance with 21 CFR Part 11, GAMP 5, Data Integrity (ALCOA+

The Model Validation Director is expected to lead and execute model validation testing processes on ... Computer Science, Management Information Systems, or Statistics/Mathematics. * Experience with data ...

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Computer System Validation information

See Bridgewater, NJ salary details

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$55

$87

How much do computer system validation jobs pay per hour?

As of Jun 28, 2026, the average hourly pay for computer system validation in Bridgewater, NJ is $55.53, according to ZipRecruiter salary data. Most workers in this role earn between $42.74 and $65.87 per hour, depending on experience, location, and employer.

What are some typical challenges faced in Computer System Validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a Computer System Validation job?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What is the salary of computer system validation?

The salary for a Computer System Validation specialist typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications such as GAMP or CSV training can influence earning potential, and roles often require knowledge of regulatory standards like FDA or ISO.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and compliance with regulations such as FDA or GMP.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It often requires knowledge of regulatory guidelines, validation protocols, and tools like GxP and 21 CFR Part 11. The field offers steady demand, opportunities for certification, and roles in quality assurance and compliance management.

Is CSV a skill?

In the context of Computer System Validation, CSV refers to Computer System Validation itself, which is a process rather than a skill. However, skills related to CSV include understanding validation protocols, regulatory requirements, and proficiency with validation tools and documentation. These skills are essential for professionals performing CSV tasks in regulated industries like pharmaceuticals and biotech.
What are popular job titles related to Computer System Validation jobs in Bridgewater, NJ? For Computer System Validation jobs in Bridgewater, NJ, the most frequently searched job titles are:
What job categories do people searching Computer System Validation jobs in Bridgewater, NJ look for? The top searched job categories for Computer System Validation jobs in Bridgewater, NJ are:
What cities near Bridgewater, NJ are hiring for Computer System Validation jobs? Cities near Bridgewater, NJ with the most Computer System Validation job openings:
Senior Validation Manager

Senior Validation Manager

Catapult

Princeton, NJ • On-site

Full-time

Posted 8 hours ago


Job description

The Senior Validation Manager is leading the site validation program and all qualification and validation activities at the Erytech, Princeton site, NJ. Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment. In this role, you will define, implement and maintain the validation program for the site, ensuring compliance to the company quality guideline, FDA regulatory requirements, and cGMP regulations.
RESPONSIBILITIES
  • The ideal candidate will have strong understanding of risk-based approach to validation, related to aseptic process and environmental control and extended experience with risk assessment including FMEA and AMDEC.
  • Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality teams.
  • Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
  • Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality team.
  • Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
  • The role includes writing, reviewing and coordinating documents required for Commissioning/Qualification/Validation such as but not limited to URS, Risk Assessment, System impact assessment, Validation master plan, in a cGMP manufacturing environment.
  • Lead the overall validation strategies and validation master plans.
  • Compile validation packages and ensure all required documentation is complete.
  • Responsible for the implementation and execution of the periodic system reviews and requalification activities.
  • Lead investigation related to deviations and discrepancies with impact on validation.
  • Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.
  • Develop and maintain CQV SOPs related to equipment, facility, and computerized systems.
  • Assist in presentation of validation packages during inspections or audits.
  • Participate, as required, in the response to regulatory audit observations.
  • Recognizes potential safety and compliance problems and takes actions to rectify them.

QUALIFICATIONS
  • Bachelor's degree in Engineering, Science, or related technical field.
  • Minimum 10 years applicable experience of CQV activities in a cGMP manufacturing environment and on aseptic processes.
  • Expert in Quality Risk Management (Performing Risk assessments and using results for determination of test strategies).
  • Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) related to validation in a cGMP facility.
  • Experience using statistical, risk assessment, and process improvement tools.
  • Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator.
  • Ability to plan and execute Smoke / Airflow Visualization Studies.
  • Ability to recommend, judge, and make good decisions in complex situations.
  • Strong organizational skills, excellent writing, and communications skills. Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
  • Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality teams.
  • Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
  • The role includes writing, reviewing and coordinating documents required for Commissioning/Qualification/Validation such as but not limited to URS, Risk Assessment, System impact assessment, Validation master plan, in a cGMP manufacturing environment.
  • Lead the overall validation strategies and validation master plans.
  • Compile validation packages and ensure all required documentation is complete.
  • Responsible for the implementation and execution of the periodic system reviews and requalification activities.
  • Lead investigation related to deviations and discrepancies with impact on validation.
  • Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.
  • Develop and maintain CQV SOPs related to equipment, facility, and computerized systems.
  • Assist in presentation of validation packages during inspections or audits. Participate, as required, in the response to regulatory audit observations.
  • Recognizes potential safety and compliance problems and takes actions to rectify them.