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From Home Computer System Validation Jobs in Massachusetts

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ... from Genezen and other contract firms Essential The ability to report on project activity in a ...

RoslinCT US

Principal, QA- Quality Systems

Hopkinton, MA · On-site

This includes supporting review and approval of new Computer System Validation deliverables, governing procedures and training content for computerized systems, as well as supporting maintenance and ...

New

Sebela Pharma

CQV/Validation Engineer

Holbrook, MA · On-site

$33 - $43/hr

... systems. * Participate in validation and CQV projects from planning through documentation ... 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 ... R esilience & Grit in operations We are committed to overcoming challenges, learning from failures ...

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All JobsComputer System Validation JobsFrom Home Computer System Validation JobsFrom Home Computer System Validation Jobs in Massachusetts

From Home Computer System Validation information

Is computer system validation a good field?

Computer system validation is a specialized field within quality assurance and regulatory compliance, primarily in industries like pharmaceuticals and healthcare. It involves ensuring that computer systems meet regulatory standards through documentation, testing, and validation protocols, often requiring knowledge of GxP regulations and validation tools. The field offers steady demand and opportunities for certification and skill development.

What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?

AspectFrom Home Computer System ValidationFrom Home Quality Assurance Specialist
CertificationsGxP validation, 21 CFR Part 11ISO 9001, QA certifications
Work EnvironmentPrimarily remote, focused on system testing and validationRemote or onsite, focused on process audits and compliance
Industry UsagePharmaceutical, biotech, healthcareManufacturing, software, healthcare
Job FocusEnsuring computer systems meet regulatory standardsEnsuring overall quality processes and compliance

From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.

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From Home Computer System Validation jobs near you

Principal Computer System Validation Specialist

Astellas Pharma, Inc.

Westborough, MA • On-site

$105K - $150K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 16 hours ago

Job description

Principal Computer System Validation Specialist
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & Scope
The Computer System Validation (CSV) Lead is responsible for developing, executing, and maintaining the validation strategy for GxP-regulated computerized systems supporting manufacturing, laboratory, and quality operations. This role ensures that all systems comply with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, and that validation deliverables are developed in alignment with corporate and industry best practices.
Role and Responsibilities
  • Lead the planning and execution of validation projects for GxP computerized systems (manufacturing, laboratory, and quality).
  • Author and/or review CSV deliverables including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), IQ/OQ/PQ protocols, and summary reports.
  • Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable company SOPs and policies.
  • Collaborate with cross-functional teams (IT, QA, Manufacturing, Lab, and vendors) to define validation scope, strategy, and deliverables.
  • Lead impact assessments for software upgrades, patches, and configuration changes; ensure continuous validation state is maintained.
  • Support data integrity initiatives and periodic review programs.
  • Manage audit readiness for all validated systems; support internal and external inspections (FDA, EMA, MHRA, etc.).
  • Develop and maintain validation templates, SOPs, and training programs.

Required Qualifications
  • Bachelor's degree in computer science, Engineering, Life Sciences, or related discipline.
  • Minimum 5-8 years of experience in computer system validation or IT quality compliance within the pharmaceutical or biotech industry.
  • Deep understanding of GxP Principals, GAMP 5 lifecycle methodology, and 21 CFR Part 11 / Annex 11 compliance.
  • Experience leading validation of enterprise and laboratory systems such as LIMS, MES, QMS, ERP, or data historians (e.g., OSI PI, Empower, SAP, LabWare, etc.).
  • Strong technical writing and documentation skills with attention to detail.
  • Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.

Preferred Qualifications
  • Master's Degree (MBA, MIS, or related field)
  • Experience with cloud-based or SaaS GxP systems
  • Familiarity with data integrity, cybersecurity, and IT infrastructure qualification (IQ of servers, networks, virtualization).
  • Project management or Lean Six Sigma certification

Location and Working Environment
This position is based in Westborough, MA. Remote work from anywhere in the US is available.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
What awaits you at Astellas?
  • Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
  • Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
  • Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
  • A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors
Values: Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as 'One Astellas', working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.
Salary Range
$105,280-$150,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)
Benefits:
  • Medical, Dental and Vision Insurance
  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
  • 401(k) match and annual company contribution
  • Company paid life insurance
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
  • Long Term Incentive Plan for eligible positions
  • Company fleet vehicle for eligible positions
  • Referral bonus program

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