Electronic engineer h1.location_city
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Electronic engineer • pembroke pines fl
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Quality Engineer - CSV / GxP Manufacturing.Monday-Friday | 8:00 AM - 5:00 PM.Month Contract | Possible Extension / Temp-to-Perm.Quality professional with strong CSV, GxP, and manufacturing systems ...[show_more][last_updated.last_updated_variable_days]
A growing firm is looking for their next .This is a great company to work with, amazing benefits and growth opportunities.Bachelor's degree in Civil Engineering.Proficient in MicroStation, OpenRoad...[show_more][last_updated.last_updated_variable_days]
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WeighPack has become a leader in developing and manufacturing Packaging Machinery solutions worldwide alongside our partner companies in the US, Italy, and China.Our diverse and multi-disciplined t...[show_more][last_updated.last_updated_30]
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If you picture yourself doing great things that make a difference in the lives of others, Turner is the place to be.Turner Construction is an industry leading commercial construction general contra...[show_more][last_updated.last_updated_30]
We're Social Mobile, one of the fastest growing technology companies in Florida.As a mobility solutions provider, we offer services critical to organizations that are looking to bring to market inn...[show_more][last_updated.last_updated_variable_days]
Accepting no less than the absolute best, our client has climbed to the top, gaining a reputation for both excellence and satisfaction.Working at this company will give you the opportunity to work ...[show_more][last_updated.last_updated_30]
The Hardware Test Engineer is responsible for planning, developing, executing, and automating test strategies to verify and validate electronic hardware designs.This role works closely with hardwar...[show_more][last_updated.last_updated_variable_days]
Senior Software Engineer (C/C++ & Python, Networking Domain).Quvia is the AI-powered quality of experience (QoE) management platform for things that move like ships and planes, transforming connect...[show_more][last_updated.last_updated_variable_days]
Every year huge investments are made on construction projects that support the Navy’s high-tech fleet of ships, aircraft, equipment, and personnel.At the center of these projects is a talented grou...[show_more][last_updated.last_updated_variable_days]
At Vector Security We Think Big, Do the Right Thing, and Make a Difference Every Day! If this is how you like to work, we’d like to invite you to join our team as an Electronic Systems Technician!....[show_more][last_updated.last_updated_variable_days]
One of the most-trusted Integrated Security providers in the United States is targeting strong growth in the.This organization has been providing elite solutions to it's customers for over 40 years...[show_more][last_updated.last_updated_variable_days]
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[job_card.job_description]
Quality Engineer - CSV / GxP Manufacturing
Davie, FL (Onsite)
Monday-Friday | 8:00 AM - 5:00 PM
6-Month Contract | Possible Extension / Temp-to-Perm
Sigma, Inc.
Sigma, Inc. is seeking a Quality Engineer to support computer system validation (CSV) and digital manufacturing systems at our onsite location in Davie, Florida. This role is ideal for a Quality professional with strong CSV, GxP, and manufacturing systems experience who thrives at the intersection of Quality, Engineering, and IT.
Key Responsibilities
Computer System Validation (CSV)
Act as Quality reviewer/approver for regulated systems including:
Education
Davie, FL (Onsite)
Monday-Friday | 8:00 AM - 5:00 PM
6-Month Contract | Possible Extension / Temp-to-Perm
Sigma, Inc.
Sigma, Inc. is seeking a Quality Engineer to support computer system validation (CSV) and digital manufacturing systems at our onsite location in Davie, Florida. This role is ideal for a Quality professional with strong CSV, GxP, and manufacturing systems experience who thrives at the intersection of Quality, Engineering, and IT.
Key Responsibilities
Computer System Validation (CSV)
- Review, approve, and maintain CSV lifecycle documentation including:
- VMP, URS, FRS, HDS
- Risk Assessments, IQ/OQ/PQ
- RTM and Validation Summary Reports
- Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ Data Integrity principles
- Evaluate system changes through change control, assessing GxP impact and validation requirements
- Support periodic reviews and re-validation of existing computerized systems
Act as Quality reviewer/approver for regulated systems including:
- MES / EBR platforms (Werum Client-X or similar)
- Process Historians (OSIsoft PI, PI Vision, or equivalent)
- Advanced analytics tools (Seeq for GxP trending)
- Empower and other laboratory systems
- Data acquisition and interfaces
- Time stamping and audit trails
- User access controls
- Electronic records and electronic signatures
- Segregation of GxP vs non-GxP analytics use cases
- Assess and approve data flows, integrations, and interfaces
- Support FDA, EMA, and internal audits related to computerized systems
- Ensure continuous inspection readiness
- Partner with Engineering, Automation, MS&T, IT, and Operations
- Provide Quality input during:
- Project design
- FAT / SAT
- Commissioning and qualification phases
- Enable efficient project execution while avoiding over-validation
Education
- Master's degree in Engineering, Computer Science, Life Sciences, or related field
(Recent graduates encouraged if experience requirements are met)
- Minimum 3 years in pharmaceutical or regulated manufacturing
- At least 2 years within a Quality organization
- 3+ years of hands-on CSV experience reviewing and approving validation documentation
- Direct experience supporting manufacturing or utilities systems (not lab-only)
- CSV lifecycle & GAMP 5
- 21 CFR Part 11 / Annex 11
- Data Integrity (ALCOA+)
- Change control, deviations, and CAPA systems
- MES / EBR, Process Historians, and GxP analytics platforms
- Experience with:
- Werum Client-X
- Seeq
- PI Vision
- Power BI (regulated trending)
- Agile or Lean validation approaches
- C&Q integration with CSV
- Participation in FDA inspections
- Industry 4.0 or site digitalization initiatives
- Risk-based decision making with strong compliance focus
- Excellent documentation review and technical writing skills
- Ability to challenge constructively and offer solutions
- Comfortable working across Quality, Engineering, and IT
- Pragmatic, business-enabling mindset