Top 6298 Computer system validation Jobs

Computer System Validation Specialist
Quality Chemical Laboratories —Wilmington, NC
- Multiple hires
- Mid-level
- 2 years
- Communication skills
- Opportunities for advancement
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14d
Computer System Validation Engineer
Katalyst Healthcares & Life Sciences —New Wilmington, PA
- Contract
- 8 years
- Senior level
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Computer System Validation (CSV) Engineer
Kashiv BioSciences, LLC —Piscataway, NJ
- Extended hours
- 5 years
- Bachelor's degree
- Travel
Computer System Validation Lead / Program Manager
Veeva Systems —Remote
- $85,000 - $120,000 a year
- Full-time
- Remote
- Engineering
- 3 years
- Product management
- Paid holidays
- Health insurance
Computer System Validation
Validation & Engineering Group —Manatí Municipio, PR
- Mid-level
- Data entry
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Computer System Validation Lead
Arrayo —Boston, MA
- Computer Science
- Mentoring
- Training & development
Computer System Validation Engineer
Avid Bioservices —Tustin, CA
- $82,000 - $104,400 a year
- Full-time
- Computer Science
- Bachelor of Science
- Engineering
- Health insurance
- Dental insurance
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Computer System Validation Lead
Tata Consultancy Services —Wilmington, DE
- $100,000 - $120,000 a year
- Computer Science
- 8 years
- Bachelor's degree
- Commuter assistance
- Health insurance
Computer System Validation Engineer
Ofni Systems —Raleigh, NC
- Bachelor of Science
- Mid-level
- Communication skills
Analyst - Computer Software Validation (Remote)
Veeva Systems —Remote
- $60,000 - $125,000 a year
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- English
- Paid holidays
- Health insurance
Computer System Validation Manager
Ofni Systems —Raleigh, NC
- Computer science
- Computer Science
- Bachelor of Science
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
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CSV Lead/ Computer System Validation Lead
Compli —Philadelphia, PA
- Full-time
- Bachelor of Science
- Organizational skills
- Senior level
- Travel reimbursement
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GxP System Engineer
Katalyst Healthcares & Life Sciences —Norwood, MA
- Contract
- 6 years
- Computer Science
- Engineering
Quick Apply
Validation Engineer/CSV Engineer
Katalyst Healthcares & Life Sciences —Walnut Creek, CA
- Multiple hires
- Engineering
- Mid-level
- Software development experience
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Lead Computer Systems Validation (CSV) Engineer (W)
Cellipont Bioservices —The Woodlands, TX
- Full-time
- Computer Science
- Bachelor of Science
- Continuous improvement
- Paid holidays
- Tuition reimbursement
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Director, Software Validation
STAAR Surgical —Lake Forest, CA
- $200,000 - $240,000 a year
- Oracle
- Computer Science
- 5 years
Principal Computer System Validation Specialist
Astellas —Westborough, MA
- $105,280 - $150,400 a year
- Hybrid work
- Computer Science
- 5 years
- Training & development
- Health insurance
- Dental insurance
2d
Senior Computer Systems Validation Engineer
Vaxcyte —San Carlos, CA
- $164,000 - $190,000 a year
- Hybrid work
- 7 years
- Azure
- Computer Science
CSV Validation & Testing Lead Life Sciences
Katalyst Healthcares & Life Sciences —San Diego, CA
- Contract
- Analysis skills
- Senior level
- Communication skills
Quick Apply

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Computer System Validation Specialist

Quality Chemical Laboratories -
Wilmington, NC

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Job Details

14 days ago

Benefits

Opportunities for advancement
Childcare

Qualifications

Data integrity assurance
GAMP
Project documentation
Team leadership
Test Case Documentation (Quality assurance practices)
Pharmaceutical regulatory compliance
FDA 21 CFR Part 11
Technical report writing
Project management experience in manufacturing
Data summary reports
Quality reports
Data integrity and documentation
System testing
Managing projects
Technical troubleshooting support
Cross-functional collaboration
Cross-functional communication
Test Planning (Quality assurance practices)

Full Job Description

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Computer System Validation Specialist.

Responsibilities:

Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle. Documentation includes Computer System Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
Track and resolve deviations/exceptions during qualification activities.
Work with company management to implement changes and upgrades to computer systems
Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications
Communicate Computer System Validation approaches and requirements during audits.
Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes

Qualifications:

Two (2) years of experience with Computer System Validation in GxP environment (preferably pharmaceutical industry).
Experience in writing computer system test scripts, validation protocols and summary reports
Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation to complete tasks
Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution
Capable of managing multiple sub-projects, duties and tasks
Effective at communicating clearly and concisely, both orally and in writing
Able to work both independently and as a member of a cross-functional project team

Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.

QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility.

QCL is an equal opportunity employer.

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