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Full Time Computer System Validation Jobs in Connecticut

Honeywell

Automation & Validation Engineer

Northford, CT · On-site

$85K - $106K/yr

It is a global leader in commercial fire systems and commercial security products. The primary ... The custom test framework involves robotics, computer vision, distributed computing and sensor ...

Honeywell

Automation & Validation Engineer

Northford, CT · On-site

$85K - $106K/yr

It is a global leader in commercial fire systems and commercial security products. The primary ... The custom test framework involves robotics, computer vision, distributed computing and sensor ...

Cadence Inc

Validation Engineer II

Suffield, CT · On-site

$83K - $105K/yr

Monitor system performance and lead requalification activities. * Qualify suppliers and vendors ... Requires clear communication, computer use, and occasional physical movement around facility.

NerdsToGo

Computer Technician

Guilford, CT · On-site

$35K - $50K/yr

System repair and upgrades * Software upgrade and installation * One-on-one training Qualifications ... Valid driver's license and a clean driving record * Must be willing to submit to mandatory ...

Noblis

Computer Engineer III

Groton, CT · On-site

$110K - $130K/yr

Experience using the NAVWAR System Operational Verification Test (SOVT) Preparation and Execution ... Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible ...

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All JobsComputer System Validation JobsFull Time Computer System Validation JobsFull Time Computer System Validation Jobs in Connecticut

Full Time Computer System Validation information

What is the difference between Full Time Computer System Validation vs Quality Assurance Specialist?

AspectFull Time Computer System ValidationQuality Assurance Specialist
CertificationsGAMP, CSV training, GMP knowledgeISO, Six Sigma, GMP certifications
Work EnvironmentPharmaceutical, biotech, regulated industriesManufacturing, healthcare, regulated industries
Primary FocusValidating computer systems and softwareEnsuring overall quality processes and compliance

Full Time Computer System Validation specialists focus on verifying that computer systems meet regulatory standards, primarily in pharma and biotech sectors. Quality Assurance Specialists oversee broader quality processes, including audits and compliance. While both roles require GMP knowledge and industry certifications, CSV roles are more technical and system-specific, whereas QA roles encompass overall quality management.

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Full Time Computer System Validation jobs near you

Senior Computer Systems Validation Engineer

CooperCompanies

Trumbull, CT • On-site

Full-time

Medical, Retirement, PTO

Re-posted 22 days ago

Job description


About CooperSurgical
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Scope:
The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate CSV strategy to meet all applicable regulations.
Job Summary:
The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk-based, inspection-ready validation culture across the organization.
Responsibilities
  • Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high-risk programs throughout the systems life cycle.
  • Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA.
  • Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems).
  • Drive inspection readiness and continuous improvement in CSV team.
  • Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology.
  • \Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV.
  • Provide guidance with functional/end user requirements, compliance, and system specifications, and ensure proper documentation is maintained to drive operational excellence.
  • Provide test execution training and assist teams with discrepancy management.
  • Support process owners for quality management systems and associated policies, procedures, and work instructions.
  • Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements. Review and identify critical issues.
  • Ensure compliance with internal and external computer system lifecycle policies and regulations.
  • Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance.
  • Ensure issues are identified, tracked, reported, and resolved in a timely manner.
  • Perform other duties as assigned.

Travel: This position may require 5-10% domestic and/or foreign travel.
Qualifications
Knowledge, Skills and Abilities:
  • Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems.
  • Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies.
  • Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports.
  • Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent system.
  • Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971.
  • Ability to effectively engage and collaborate with cross-functional teams, including IT, Quality Assurance, Validation, and business project stakeholders.
  • Knowledge of business enterprise functions and processes. Experienced in organizing meetings.
  • Strong analytical and problem-solving skills with ability to identify issues, evaluate options, and implement effective solutions.
  • Ability to adapt to a fast and dynamic environment and effectively engage with various functional and technical teams.
  • Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency.
  • Strong written, verbal, and interpersonal communication skills (ability to communicate effectively with all stakeholders).
  • Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments.
  • Ability to work independently and within teams (collaborative environment); self-motivated, self-directed, and detail oriented.
  • Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat.
  • Experience/knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system.
  • Experience/knowledge of Waterfall, Agile, or Hybrid software development.
  • Experience/knowledge of automated systems for following activities/functions is preferred:
  • Enterprise Resource Planning (Oracle E Business Suite)
  • Document management (SharePoint)
  • Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC)
  • Change/Incident Management (ServiceNow)
  • Project/Task Management (Smartsheet/Excel spreadsheets)

Work Environment:
  • Prolonged periods of sitting, especially in front of a computer.
  • Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols.

Experience:
  • 7 +years of experience in assigned function's business process, engineering, and supporting systems for QA and Compliance departments.
  • 5+ years of experience in Computer Systems Validation.

Education:
  • Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience.

#LI-KA1
Our Benefits:
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $100,000.00 - $130,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

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