Westborough, Massachusetts, United States · Remote OK
$105k–$150k/yr
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 a…
Skills: Computer System Validation, GxP Compliance, FDA 21 CFR Part 11, EU Annex 11, GAMP 5
Boston, Massachusetts, United States · Hybrid
$121k–$226k/yr
Insurance touches people during some of the most challenging moments in their lives. Hi Marley is on a mission to transform how the P&C industry communicates, making those moments faster, easier, and more empathetic for …
Skills: AI Security Engineering, Threat Modeling, LLM Integration, Adversarial Testing, Python
Cambridge, Massachusetts, United States · Remote OK
$120k–$215k/yr
Do you want to prove, hands-on, why the world's most distributed network outperforms, and show your work? Are you the engineer who would rather demonstrate a claim than assert it? Join our innovative product marketing te…
Skills: Technical Marketing, Network Engineering, CDN, HTTP/2, HTTP/3
Bedford, Massachusetts, United States · On-site
$140k–$150k/yr
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Boston, Massachusetts, United States · Hybrid
$185k–$225k/yr
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Skills: Mechanical Engineering, HVAC Design, Team Leadership, Project Management, Sustainable Design
Framingham, Massachusetts, United States · On-site
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Skills: Lean Transformation, Strategy Deployment, Value Stream Analysis, Kaizen, A3 Problem Solving
Wilmington, Massachusetts, United States · On-site
Who We Are We are Textron Systems, best known for innovative defense technologies and services. We are a part of Textron Inc, one of the world’s leading multi-industry companies, recognized for its powerful brands such a…
Skills: Quality Management Systems, Lean Manufacturing, ISO 9001, AS9100, Root Cause Analysis
Wilmington, Massachusetts, United States · On-site
Who We Are We are Textron Systems, best known for innovative defense technologies and services. We are a part of Textron Inc, one of the world’s leading multi-industry companies, recognized for its powerful brands such a…
Skills: Quality Management Systems, Lean Manufacturing, ISO 9001, AS9100, Root Cause Analysis
Boston, Massachusetts, United States · On-site
Overview Colliers Engineering & Design is seeking a dynamic New England Bridge Leader to support our New England operations. This is a strong opportunity for a motivated professional to drive business development, build …
Skills: Bridge Engineering, Project Management, Client Management, Business Development, Technical Design
Ayer, Massachusetts, United States · On-site
$120k–$160k/yr
Summary - Job Responsibilities – Activities: AMSC is looking for an experienced Electrical Engineer that can take projects and run with them to completion. The company has an interactive and outgoing team of Profes…
Skills: Power Electronics, Circuit Design, Three-Phase Power Systems, High-Voltage Circuits, PCB Troubleshooting
Wilmington, Massachusetts, United States · On-site
Build Precision. Drive Innovation. Advance Your Career. We are seeking an experienced CNC Machinist to join our advanced prototype and precision manufacturing team. This role supports low-volume, high-mix production for …
Skills: CNC Machining, ProtoTRAK, G-code Programming, GD&T, Blueprint Reading
Wilmington, Massachusetts, United States · On-site
Build Precision. Drive Innovation. Advance Your Career. We are seeking an experienced CNC Machinist to join our advanced prototype and precision manufacturing team. This role supports low-volume, high-mix production for …
Skills: CNC Machining, ProtoTRAK, G-code Programming, GD&T, Blueprint Reading
Boston, Massachusetts, United States · On-site
Job Title: BMS Technician Department: Engineering & Maintenance Reports To: Building Superintendent FLSA Status: Non-Exempt GRADE: Union SUMMARY: Installs repairs and maintains the Authority’s electrically operated…
Skills: Electrical Circuit Setup, Preventative Maintenance, HVAC Control Systems, Fire Alarm Systems, CCTV Maintenance
Boston, Massachusetts, United States · On-site
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Skills: Building Management Systems, HVAC Operation, Lighting Systems Control, Fire Alarm Monitoring, Blueprint Reading
Waltham, Massachusetts, United States · Hybrid
$155k–$190k/yr
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team…
Skills: Analytical Development, Quality Control, Peptide Chemistry, CMC Regulatory Filings, CDMO Oversight
Plymouth, Massachusetts, United States · On-site
$30/hr–$35/hr
Job Type: Full-time Job Location: Plymouth, MA Pay: $30-35/hr Supplemental Pay: Overtime pay Performance bonus Schedule: Extended hours Monday to Friday On call Company Overview ACT Power Services was created to provide …
Skills: Preventative Maintenance, Troubleshooting, Electrical Theory, NEC Code, DC And AC Testing
Fall River, Massachusetts, United States · On-site
$30/hr–$35/hr
Job Type: Full-time Job Location: Fall River, MA Pay: $30-35/hr Supplemental Pay: Overtime pay Performance bonus Schedule: Extended hours Monday to Friday On call Company Overview ACT Power Services was created to provid…
Skills: Preventative Maintenance, Troubleshooting, Electrical Theory, NEC Code, DC And AC Testing
Somerville, Massachusetts, United States · Hybrid
VIA is making an impact, and so can you. VIA is the digital infrastructure company mission-critical organizations rely on when speed and security matter most. The Department of War, government agencies, and global enterp…
Skills: Backend Engineering, Mobile Development, Crypto/Web3, Data Science, Data Engineering
Wilmington, Massachusetts, United States · On-site
About This Role We believe people should love what they do – in this role, you will be responsible for: Examining work environments for various physical, chemical, biological, and environmental hazards and stresses and m…
Skills: Environmental Compliance, Risk Assessment, OSHA Regulations, EPA Regulations, Hazardous Materials Transport
Wilmington, Massachusetts, United States · On-site
About This Role We believe people should love what they do – in this role, you will be responsible for: Examining work environments for various physical, chemical, biological, and environmental hazards and stresses and m…
Skills: Environmental Compliance, Risk Assessment, OSHA Regulations, EPA Standards, Hazardous Materials Transport
Westborough, Massachusetts, United States • Remote OK
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Lead the development and execution of validation strategies for GxP-regulated computerized systems in manufacturing, laboratory, and quality operations. Ensure continuous compliance with regulatory requirements and manage audit readiness for all validated systems.
Requires a Bachelor's degree in Computer Science, Engineering, or Life Sciences with 5-8 years of CSV experience in the pharmaceutical or biotech industry. Must have deep knowledge of GAMP 5, 21 CFR Part 11, and experience with enterprise systems like LIMS or SAP.
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
Required Qualifications
Preferred Qualifications
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?
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:
#LI-TR1
Astellas is committed to turning innovative science into VALUE for patients.
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. Visit our Global Astellas LinkedIn Community Guidelines to learn more about interacting with this page: https://www.astellas.com/en/global-linkedin-community-guidelines
Offices: 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, JP
Based on 6029 listings with disclosed salaries, most engineering jobs in Massachusetts pay between $87k–$205k per year. Individual offers vary with seniority, company size, and specialization.
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