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Computer System Validation Jobs in Massachusetts

Emvia, Inc.

Automation Validation Lead

Andover, MA · On-site +1

Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...

Staffingine LLC

Data Warehouse BI Tester

Boston, MA · On-site

Extensive experience with pharma companies, including strong CSV (Computer System Validation) skills * Capable of executing both GxP and non-GxP programs/projects * Excellent communication skills ...

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Computer System Validation information

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$11

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$93

How much do computer system validation jobs pay per hour?

As of Jun 9, 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 are the most commonly searched types of Computer System Validation jobs in Massachusetts? The most popular types of Computer System Validation jobs in Massachusetts are:
What are popular job titles related to Computer System Validation jobs in Massachusetts? For Computer System Validation jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Computer System Validation jobs in Massachusetts look for? The top searched job categories for Computer System Validation jobs in Massachusetts are:
What cities in Massachusetts are hiring for Computer System Validation jobs? Cities in Massachusetts with the most Computer System Validation job openings:
Computer System Validation jobs near you

Senior Manager, Quality Systems

Azurity Pharmaceuticals - US

Woburn, MA • Hybrid

Other

Posted 22 days ago

Job description

Brief team/department description:

Job Type: Full-Time

The Manager, Documentation Management plays a leadership role in sustaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position is responsible for ensuring the integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, with a strong focus on adherence to GxP and regulatory requirements such as 21 CFR Part 11 and EU Annex 11.

Principle Responsibilities:

  • Lead the development, implementation, and continuous improvement of a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal standards.
  • Oversee the validation, integrity, and lifecycle compliance of electronic quality systems, including enterprise-wide document management platforms.
  • Manage the Documentation Management System, ensuring efficient control, authorship, review, approval, and periodic revision of all controlled documents (e.g., SOPs, policies, work instructions) in alignment with lifecycle and regulatory requirements.
  • Direct document lifecycle activities, ensuring timely execution and alignment with GxP standards and applicable regulatory frameworks.
  • Develop and lead GxP training strategies and programs to ensure that functional teams maintain a high level of quality awareness and compliance readiness.
  • Drive cross-functional continuous improvement initiatives aimed at optimizing quality system performance and documentation processes.
  • Lead the planning, oversight, and execution of the Computer System Validation (CSV) program to ensure compliance with 21 CFR Part 11, EU Annex 11, and internal validation requirements.
  • Serve as a point of contact for internal and external audits and regulatory inspections, ensuring documentation systems are readily accessible, compliant, and defensible.

Qualifications and Education Requirements:

  • Bachelor's degree in Life Sciences, Pharmacy, Quality, or a related field (advanced degree preferred).
  • 5-7 years of progressive experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry.
  • Strong working knowledge of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulatory standards.
  • Proven experience managing electronic Document Management Systems and executing Computer System Validation (CSV) activities.
  • Demonstrated leadership, project management, and cross-functional collaboration skills.
  • Exceptional attention to detail, organizational capability, and ability to manage multiple priorities in a fast-paced, regulated environment.

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