63 computer system validation jobs at 54 companies in Massachusetts
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Principal Computer System Validation Specialist
Westborough, Massachusetts, United States
$105k-$150k/yrHybridFull Time
Astellas PharmaTokyo Stock Exchange: 4503: Global developing and manufacturing pharmaceutical therapies for patients.
5+ YOEBachelor's degree, 5–8 years computer system validation in pharma/biotech, deep knowledge of GxP/GAMP 5/21 CFR Part 11/Annex 11, experience validating LIMS/MES/QMS/ERP/OSI PI/Empower/SAP/LabWare, strong technical writing and project management.
LIMS, MES, QMS, ERP, OSI PI, Empower, SAP, LabWare, GAMP 5, 21 CFR Part 11, EU Annex 11
Computer System Validation - Senior Consultant - Life Sciences
New York or Boston or Chicago or Hoboken or McLean or Pittsburgh or Philadelphia or Washington
$94k-$155k/yrHybridFull Time
EY: Global firm providing audit, tax, and professional consulting services.
3+ YOEBachelor's degree in a technical field and 3+ years life sciences validation experience; strong CSV, SDLC/Agile, GxP/regulatory and risk-based validation knowledge.
Senior Quality Engineer, Computer System Validation (CSV)
Northbridge or Watertown
$142k-$179k/yrHybridFull Time
EyePoint PharmaceuticalsNASDAQ: EYPT: Clinical-stage developing sustained-delivery treatments for retinal diseases.
3+ YOEBachelor's degree and 3+ years GxP computerized system validation experience in pharma/biotech/medical device; knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9/Q10 and FDA CSA; strong documentation, risk management, and project leadership skills.
GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9, ICH Q10, FDA Computer Software Assurance (CSA), RCA, FMEA, VSM, ERP
Validation Analyst/Senior Validation Analyst, Clinical Research
North Carolina or New Jersey or New York or Georgia or Pennsylvania or Illinois or Texas or Maryland or Massachusetts or Florida or Virginia
$76k-$126k/yrRemoteFull Time
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
5+ YOE5+ years validating regulated computer systems (CSV) in GxP environments; SDLC experience; knowledge of FDA 21 CFR Part 11, GAMP5, risk-based validation; strong writing and stakeholder skills.
Jira, Azure DevOps, HP ALM, CTMS, eTMF, EDC, LIMS, ERP, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Project
Laconia or Maine or New Hampshire or Vermont or Massachusetts or Connecticut or Rhode Island
$800-$950/hrRemotePart Time
Community College System of New Hampshire: Providing public higher education and career training across New Hampshire.
Master's in subject preferred (or equivalent combination of degrees and professional/teaching experience). Valid driver's license required. Familiarity with learning management systems preferred.
Group 1 AutomotiveNYSE: GPI: Automotive retailer operating dealerships, collision centers, and service departments.
2+ YOETwo or more years in automotive parts; high school diploma; valid driver's license; strong customer service; ability to price parts and use computer systems.
RoslinCT: Contract manufacturing for advanced cell and gene therapies.
8+ YOE8+ years QA experience in pharma/biotech GMP environment, 3+ years software validation QA, knowledge of Computer System Validation, GAMP, 21 CFR Part 11 and Annex 11, ability to support audits and drive quality systems improvements.
GAMP, Computer System Validation (CSV), 21 CFR Part 11, Annex 11
ArdelyxNASDAQ: ARDX: Discovers and develops medicines for unmet medical needs.
8+ YOEBachelor's degree and 8+ years CV or related life sciences experience; expertise in computer systems validation, risk-based validation, GxP/FDA regulations, SDLC, test management, and cross-functional coordination.
test management tools, virtualization, directory services, storage, DBMS
Lexington Public Schools: Providing K-12 public education to students in Lexington, Massachusetts.
8+ YOEMassachusetts Master electrician license, valid driver’s license, HS diploma or equivalent, 8+ years electrical trade experience, proficiency with diagnostics and building systems, basic computer skills, ability to lift 50 lbs and work in varied environments.
MCPHS: Private university providing healthcare and life sciences education.
High school diploma or GED, valid driver’s license, basic knowledge of building systems (HVAC, Plumbing, Electrical), basic carpentry, hand tools, basic computer skills, ability to multitask, English reading/writing, ability to work off-hours/weekends.
HVAC systems, Plumbing, Electrical systems, Carpentry tools, Hand tools, Computer
Green Thumb IndustriesCanadian Securities Exchange: GTII: Produces and distributes cannabis consumer packaged goods and retail services.
1+ YOE1+ year customer service experience; must be 21+; valid driver’s license or state ID; pass state cannabis background checks; ability to lift up to 30 lb, operate POS/computer systems, and work varied shifts including weekends and nights.
POS, computer, word processing, database management, spreadsheet applications, email
Harr Motor Group: Selling and servicing new and used motor vehicles.
2+ YOECustomer-service experience (automotive preferred), strong communication and organizational skills, proficiency with computer systems, valid driver’s license, ability to stand and work around vehicles.
Integritus Healthcare: Providing post-acute healthcare and senior residential services.
2+ YOETwo years of experience required; MA Pharmacy Technician certification; HS diploma; valid driver’s license; able to travel to facilities; strong computer and dispensing system skills.
Pharmacy dispensing software, Unit dose dispensing system, IV admixture systems
McGovern Automotive Group: Automotive dealer group operating new and used vehicle dealerships.
Provide diesel and automotive service including engine analysis, diagnostics, suspension, brakes, and computer-controlled systems; must have valid driver's license and ability to communicate and work in a team.
Asbury Automotive GroupNYSE: ABG: Operates franchised car dealerships and provides vehicle maintenance services.
Experience as service advisor preferred; valid driver's license; must be 18+; excellent customer service and communication; ability to pass background and drug tests; proficient with computers and phone systems.
Valid driver's license, excellent customer service and communication skills, ability to multitask, basic automotive knowledge, ability to perform light physical tasks and use dealership computer systems.
Summit Companies: Provides fire protection and life safety services.
3+ YOEHS diploma, current fire sprinkler license, valid driver's license, 3+ years installing pipe systems and valves, ability to read blueprints, operate computer/tablet, troubleshoot, and train apprentices.