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Computer System Validation Jobs in Massachusetts

Sebela Pharma

CQV/Validation Engineer

Holbrook, MA · On-site

$33 - $43/hr

Support equipment, utility, facility, process, cleaning, and computerized system validation ... Auto CAD experience preferred. * Flexible to work overtime (paid) as needed. Pay Range: $33.00 ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV experiences including as a Validation lead Essential The ability to communicate with employees of all ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV experiences including as a Validation lead Essential The ability to communicate with employees of all ...

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$11

$59

$93

How much do computer system validation jobs pay per hour?

As of Jul 16, 2026, the average hourly pay for computer system validation in Massachusetts is $59.32, according to ZipRecruiter salary data. Most workers in this role earn between $45.67 and $70.34 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 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 regulatory compliance.

What degree is best for cis jobs?

For Computer System Validation (CSV) roles, a bachelor's degree in computer science, information technology, life sciences, or engineering is typically preferred. Relevant certifications such as GxP or validation-specific training can enhance job prospects, and strong knowledge of regulatory requirements like FDA or EMA guidelines is beneficial.

What is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools, which can influence compensation.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Massachusetts as of July 2026, with employment types broken down into 1% As Needed, 79% Full Time, 17% Part Time, 1% Temporary, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $123,391 per year, or $59.3 per hour.

OT Cybersecurity & CRA Compliance Architect

TechYantram Solutions

Bedford, MA • On-site

Other

Posted 21 days ago

Job description

OT Cybersecurity & CRA Compliance ArchitectIntroduction:

The OT Cybersecurity & CRA Compliance Architect will be responsible for implementing and conducting gap assessments for the EU Cyber Resilience Act (CRA), IEC 62443/ISA99, ISA 95, GMP, URS, NFR, FS, DS, IQ, OQ, PQ, audit trails, electronic records, RBAC, SCADA, and Rockwell systems. The role will also involve developing a global OT reference architecture and ensuring compliance with GMP & FDA 21 CFR Part 11 regulations, as well as Computer System Validation (CSV).

Responsibilities:
  • Implementing CRA requirements and conducting gap assessments to ensure compliance
  • Developing and maintaining a global OT reference architecture
  • Ensuring compliance with GMP & FDA 21 CFR Part 11 regulations
  • Conducting Computer System Validation (CSV) for OT systems
  • Implementing and managing audit trails and electronic records
  • Implementing Role-Based Access Control (RBAC) for OT systems
  • Working with SCADA and Rockwell systems to ensure cybersecurity and compliance
Requirements:Required Skills:
  • Experience with EU Cyber Resilience Act (CRA) implementation and gap assessments
  • Knowledge of IEC 62443/ISA99 cybersecurity standards
  • Understanding of ISA 95, GMP, URS, NFR, FS, DS, IQ, OQ, and PQ in the context of OT systems
  • Experience with audit trails and electronic records in an OT environment
  • Experience with Role-Based Access Control (RBAC) implementation
  • Experience working with SCADA and Rockwell systems
Preferred Skills:
  • Certifications in cybersecurity or compliance (e.g., CISSP, CISA, CRISC)
  • Experience with Computer System Validation (CSV) for OT systems
  • Experience developing global reference architectures for OT systems

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