Top 90 Trackwise System Engineer Jobs

Computer System Validation Engineer - Medical Device Equipment & Regulations
Macpower Digital Assets Edge Private Limited —San Juan, PR
- $45 an hour
- Organizational skills
- Software development experience
- Senior level
Quick Apply
Sr Lead CQV and CSV Engineer
VTI Life Sciences —Thousand Oaks, CA
- Temporary
- 8 years
- Senior level
Quick Apply
Validation Engineer
Katalyst Healthcares & Life Sciences —Bothell, WA
- Contract
- 5 years
- Engineering
- Senior level
Quick Apply
Sr CQV and Packaging Engineer - Thousand Oaks, CA
VTI Life Sciences —Thousand Oaks, CA
- $90,000 - $120,000 a year
- Full-time
- 3 years
- Senior level
- Communication skills
- 401(k) matching
Quick Apply
MES Engineer
Validation & Engineering Group —Morrisville, NC
- Full-time
- 7 years
- Computer Science
- Engineering
Quick Apply
Verification & Validation Engineer
Tata Consultancy Services —Milpitas, CA
- $100,000 - $120,000 a year
- Computer Science
- Bachelor's degree
- Senior level
- Commuter assistance
- Health insurance
Supplier Quality Engineer
Katalyst Healthcares & Life Sciences —Northridge, CA
- Contract
- In-person
- Senior level
- Leadership
Quick Apply
Sr. Engineer
PRPDG —Juncos, PR
- $45 - $50 an hour
- Full-time
- Spanish
- Doctoral degree
- 5 years
Quick Apply
Senior Quality Systems Engineer
Avanos Medical —Alpharetta, GA
- Full-time
- Management
- Engineering
- Master's degree
- Health insurance
- 401(k) matching
Senior Engineer (multiple positions)
Kelly Services —Juncos, PR
- $45 an hour
- Multiple hires
- Spanish
- Engineering
- English
- Paid holidays
- Disability insurance
Quick Apply
Manufacturing Equipment Validation Engineer
Hikma Pharmaceuticals —Bedford, OH
- $59,900 - $120,450 a year
- Full-time
- Engineering
- Master's degree
- Supervising experience
- Paid parental leave
- Paid holidays
Quick Apply
14d
Compliance Engineer
Validation & Engineering Group, Inc —Gurabo, PR
- Engineering
- Mid-level
- Organizational skills
Quick Apply
Validation Engineer
Celltrion Branchburg, LLC —Branchburg, NJ
- $72,000 - $116,000 a year
- Full-time
- Microsoft Outlook
- Computer Science
- Engineering
- Paid holidays
- Disability insurance
Quick Apply
Equipment Validation Engineer
ALLIANCE BIOTECH SOLUTIONS LLC —Raleigh, NC
- Full-time
- 5 years
- Mid-level
- Communication skills
- Disability insurance
- Dental insurance
Quick Apply
Principal Engineer l, Upstream Manufacturing
WuXi Biologics —Cranbury, NJ
- Bachelor of Science
- Bachelor's degree
- Travel
Controls Engineer II, Operational Technology
United Therapeutics —Silver Spring, MD
- $84,000 - $120,000 a year
- Full-time
- Engineering
- Mid-level
- High school diploma or GED
- Paid parental leave
- Employee stock purchase plan
Sr Supplier Quality Engineer
Endologix —Santa Rosa, CA
- $110,000 - $127,500 a year
- Full-time
- 5 years
- Engineering
- Master's degree
- Commuter assistance
- Health savings account
Plant Engineer I
Evonik Industries AG —Birmingham, AL
- Online Application
- Engineering
- Mid-level
- Organizational skills
- Health insurance
CAPA Engineer II
Integra LifeSciences —Princeton, NJ
- $71,300 - $97,750 a year
- Email
- 3 years
- Master's degree
- Analysis skills
- Disability insurance
- Health insurance
Senior CSV Engineer
Katalyst Healthcares & Life Sciences —Chicago, IL
- Contract
- Hybrid work
- Oracle
- Computer Science
- Engineering
Quick Apply

I want to receive the latest job alert for Trackwise System Engineer

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

Trackwise System Engineer jobs near

Computer System Validation Engineer - Medical Device Equipment & Regulations

Macpower Digital Assets Edge Private Limited
San Juan, PR

Quick Apply

Job Details

$45 an hour

Qualifications

Data integrity assurance
Compliance risk assessment
Bug Tracking (Quality assurance practices)
Data validation techniques
Test Case Documentation (Quality assurance practices)
Systems architecture experience within technology
Strategy Development (Quality assurance practices)
Bug Reporting (Quality assurance practices)
FDA 21 CFR Part 11
ICH Q9
Data summary reports
Quality reports
Data integrity and documentation
Quality risk management
Quality control documentation
Issue tracking
Software documentation
Software development experience
Biomedical regulatory compliance
Technical project management
Defect tracking tools
Regulatory compliance analysis
Document change management
Cross-functional collaboration
Test validation method
Cross-functional communication
Test Planning (Quality assurance practices)
Stakeholder management

Full Job Description

Job Summary:

Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
Compliance Analysis, Validation Planning, Risk Assessments
Test planning and strategy
creation and execution of test protocols, scripts and reports.
Validation Summary Reports, traceability analysis.
Defect Logging and Tracking till closure.

Responsibilities:

Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
Author and update documentation to support ongoing CSV compliance.
Prepare or review all levels of validation documents including:
Validation (Strategy) Plans, User Requirement Specifications
Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs
Qualification Documents and Test Specifications (IQ, OQ, PQ)
Traceability Matrices, Risk Analysis
Validation Reports, Change Controls/ Events / Deviations etc
Assess the impact of changes proposed to computerized systems and the level of change required.
Provide validation strategy to the introduction of computerized systems.
Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc) and management on all related matters on a regular basis.

Must Have:

GxP and Regulatory Knowledge: You should have a strong understanding of Good Manufacturing Practice (GxP) regulations and their application in computerized systems, as well as knowledge of relevant regulations like FDA 21 CFR Part 11 and International Standards (e.g., EU Annex 11, ICH Q7, and GAMP 5).
Computer System Validation (CSV): You must have hands-on experience with the full lifecycle validation of computerized systems, ensuring compliance from system design to retirement. You should also be capable of developing and executing validation strategies and plans based on industry standards like GAMP 5.
Risk Assessment: You need to be able to perform risk assessments to identify potential risks and assess the impact of system changes, ensuring the right level of validation is applied.
Testing & Documentation: You should be proficient in test planning and strategy, including the creation and execution of test protocols and scripts such as IQ, OQ, and PQ. Additionally, you must have experience in defect tracking and preparing comprehensive validation reports with clear traceability.
Project Management: Strong organizational skills are essential to manage and prioritize tasks in a regulated environment, while also collaborating effectively with cross-functional teams and managing stakeholder expectations.
Change Control Management: You must be familiar with change control procedures to assess the impact of system changes and prepare or review relevant documentation, including deviations and changes to system processes.
Technical Knowledge: A good understanding of the software development life cycle (SDLC) and system architecture is necessary, along with data validation expertise to ensure the integrity and reliability of system data.
Software Tools: Familiarity with CSV tools and validation management software (e.g., Veeva Vault QMS, MasterControl, Trackwise) is important for efficient document management and validation tracking.

Quick Apply

Refine Your Search

Trackwise System Engineer jobs

Computer System Validation Engineer - Medical Device Equipment & Regulations

Sr Lead CQV and CSV Engineer

Validation Engineer

Sr CQV and Packaging Engineer - Thousand Oaks, CA

MES Engineer

Verification & Validation Engineer

Supplier Quality Engineer

Sr. Engineer

Senior Quality Systems Engineer

Senior Engineer (multiple positions)

Manufacturing Equipment Validation Engineer

Compliance Engineer

Validation Engineer

Equipment Validation Engineer

Principal Engineer l, Upstream Manufacturing

Controls Engineer II, Operational Technology

Sr Supplier Quality Engineer

Plant Engineer I

CAPA Engineer II

Senior CSV Engineer

I want to receive the latest job alert for Trackwise System Engineer

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected