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Computer Systems Validation Jobs in Bridgewater, NJ

WuXi Biologics

Senior Engineer I, Validation

Cranbury, NJ · On-site

$73K - $117K/yr

Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. * Experience in the qualification of biologics ...

Kenvue

Lead CSV Specialist - NA

Summit, NJ · On-site

$90K - $127K/yr

The Lead Computer Systems Validation Specialist (CSV) NA is responsible for the building and execution of quality into enterprise wide systems, tools, services, and infrastructure through the end-to ...

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Computer Systems Validation information

See Bridgewater, NJ salary details

$10

$55

$87

How much do computer systems validation jobs pay per hour?

As of Jun 28, 2026, the average hourly pay for computer systems 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 is the work of computer system validation?

Computer Systems 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 helps maintain data integrity, quality, and regulatory compliance in industries like pharmaceuticals and healthcare.

What is the salary of computer system validation?

The salary for a Computer Systems Validation specialist typically ranges from $70,000 to $120,000 annually, depending on experience, location, and certifications such as GxP or 21 CFR Part 11. Entry-level roles may start lower, while experienced professionals with regulatory knowledge can earn higher salaries in the pharmaceutical, biotech, or medical device industries.

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

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

Is computer system validation a good field?

Computer Systems Validation (CSV) is a vital role in regulated industries such as pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It involves skills in validation protocols, documentation, and understanding regulatory requirements like FDA or EMA guidelines, making it a stable and in-demand career path for those with technical and regulatory knowledge.

What is the difference between Computer Systems Validation vs Quality Assurance Specialist?

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

Is CSV a skill?

In the context of Computer Systems Validation, CSV is not a skill but an abbreviation for Computer System Validation, which involves verifying that computer systems meet regulatory requirements. Skills relevant to CSV include knowledge of validation protocols, regulatory standards like GxP, and proficiency with validation tools and documentation. Understanding these concepts is essential for professionals working in regulated industries such as pharmaceuticals and biotech.

What is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

What are some common challenges faced in a Computer Systems Validation (CSV) role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.
What are popular job titles related to Computer Systems Validation jobs in Bridgewater, NJ? For Computer Systems Validation jobs in Bridgewater, NJ, the most frequently searched job titles are:
What job categories do people searching Computer Systems Validation jobs in Bridgewater, NJ look for? The top searched job categories for Computer Systems Validation jobs in Bridgewater, NJ are:
Computer Systems Validation jobs near you

Associate Director - Computer Systems Validation

Celltrion Branchburg, LLC

Somerville, NJ • On-site

$135K - $180K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 2 days ago

Job description

Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products.

Celltrion Branchburg, LLC is a subsidiary of Celltrion USA, established in 2025 following Celltrion USA’s acquisition of Eli Lilly’s drug substance (DS) manufacturing facility located in Branchburg. By linking robust local manufacturing capabilities with an existing direct sales network, we aim to generate greater synergies across our operations. Looking ahead, we also anticipate expanding into the global contract manufacturing organization (CMO) sector.



Position Brand Description:

The leader of Computer System Validation and Computer Software Assurance (CSV/CSA) is responsible for leading and governing all site-wide CSV and CSA activities to ensure that computerized systems are validated, compliant, and maintained in accordance with GMP regulations, 21 CFR Part 11, and global quality standards. This role provides strategic leadership, establishes validation frameworks, and ensures the consistent execution of validation lifecycle activities across all systems supporting manufacturing, facilities/utilities, quality, laboratory, and enterprise functions. This leader serves as the primary liaison between IT and automation, Quality Assurance (QA), system owners, global teams, and vendors, ensuring alignment, inspection readiness, and sustainable compliance.


Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

  1. Lead and develop a high performing, site-wide CSV/CSA team responsible for validation execution, inclusive of resource planning, skill building, training, and inspection readiness.
  2. Define and maintain the site-wide CSV/CSA strategy for information technology (IT) and operational technology (OT) policies and procedures aligned with site, global, and regulatory expectations. This includes adherence to strategies such as validation lifecycle frameworks and risk-based validation approaches. Align IT and OT validation lifecycle approaches.
  3. Maintain and implement an annual technical continuous improvement and asset qualification monitoring (AQM) agenda.
  4. Oversee execution of validation activities across all GMP systems, including: supporting risk assessments based on system criticality and data impact, validation planning and test execution (IQ/OQ/PQ), and traceability / documentation completeness.
  5. Ensure all computerized systems remain in a validated state throughout their lifecycle. Partner with QA to maintain compliance with data integrity, audit trail, and security requirements consistent with regulatory expectations (GAMP 5, EU Annex 11, 21 CFR Part 11, etc.). Lead regulatory inspection readiness for CSV/CSA and support inspection activities.
  6. Ensure effective handover between project and operational phases of computerized systems.
  7. Influence internal and external customers/regulators/partners, including to adopt a different point of view on difficult concepts. Partner with key stakeholders to harmonize validation approaches and incorporate regulatory feedback. Benchmark through industry consortia and conferences.
  8. Provide representation where required for cross-functional and cross-site technical initiatives.

Manage Relationships with Key Stakeholders and Customers:

  1. Contribute to the site planning processes (such as business and strategic plan).
  2. Collaborate cross-functionally with manufacturing, automation, engineering, IT and quality teams to align validation scope with system criticality and business impact, ensuring on-time delivery.
  3. Network and engage internal and external expertise to enable the delivery of world class large molecule manufacturing operations to Branchburg.
  4. May be required to travel offsite to other Celltrion or partner sites within the global network, other pharmaceutical companies, conferences, networking events, or off-site training.
  5. Develop strong working relationships cross-functionally to ensure success.
  6. Represent Branchburg on cross-site teams exploring CSV/CSA optimization, best practices, and other technical excellence initiatives.


Staff Development and Management:

  1. This position involves directly managing 4 – 10 Technical Operations representatives.
  2. Provide leadership, training, coaching, and effective career development for team.
  3. Conduct annual performance reviews with team members.
  4. Ensure the company values, standards and policies are communicated to and modeled within the team.
  5. Participate in succession planning.

Resource Management:

  1. Perform and champion all work in a safe and compliant manner.
  2. Proactively support site management decisions and strategy.

Basic Requirements:

  1. Experience performing qualification of manufacturing automated equipment and computerized systems.
  2. Understanding of FDA and EU regulations and guidelines and knowledgeable of current industry trends.
  3. Have organizational and time management skills that will allow for effective prioritization of activities.
  4. Understanding of key data integrity principles to ensure requirements are aligned to appropriate testing strategies with the use of electronic data / databases.
  5. Have broad knowledge of computer systems and automated process equipment or utility systems, such as Rockwell (PLC/HMI), MES, ERP, and OSI PI Historian to develop qualification protocols meeting user and functional requirements.
  6. Have strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner within a GMP environment.
  7. Strong analytical, problem solving, and excellent interpersonal skills.


Additional Preferences:

  1. Prior leadership experience preferred.

Education Requirements:

  1. Bachelor’s degree in engineering, science, or related discipline with a minimum of 5 years’ experience in cGMP biopharmaceutical manufacturing.


This role is exempt and the anticipated compensation for this role is $135,000 - $180,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.


Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.
Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.