ZipRecruiter

Log In

1

Computer System Validation Csv Pharmaceutical Jobs in Utah

PACS

Senior HRIS Analyst

Farmington, UT · On-site

$85K - $109K/yr

... Computer System Validation Framework. • Must possess understanding of systems development life cycle, computer systems validation, application development, and systems integration. • ...

JT4, LLC

Computer Programmer

Magna, UT · On-site

Operates computer system to check out programs, troubleshoot and test systems * Monitors ... Must possess a valid, state-issued driver's license. * Must be a U.S. citizen. Benefits * Medical ...

JT4 LLC

Computer Programmer

Salt Lake City, UT · On-site

Modern embedded languages like Rust or Real-Time Operating Systems (RTOS) is a significant plus ... valid, state-issued driver's license. Must be a U.S. citizen. Benefits Medical, Dental, Vision ...

American Advanced Management, Inc

$16.50 - $20/hr

... the computer system, prepare medications, fills automated medication dispensing system with a supply of unit dose medications, procure, and fill requests for pharmaceutical supplies and deliver ...

U-Haul

Field Computer Specialist

Salt Lake City, UT · On-site

$18.50 - $22.25/hr

In this role you will be responsible for all computer and security systems in your area, traveling ... Current, valid driver's license and clean driving record Work Environment: The work involves ...

U-Haul

Field Computer Specialist

Salt Lake City, UT · On-site

$18.50 - $22.25/hr

In this role you will be responsible for all computer and security systems in your area, traveling ... Current, valid driver's license and clean driving record Work Environment: The work involves ...

next page

Showing results 1-20

All JobsComputer System Validation Csv Pharmaceutical JobsComputer System Validation Csv Pharmaceutical Jobs in Utah

Computer System Validation Csv Pharmaceutical information

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Utah?

For Computer System Validation Csv Pharmaceutical jobs in Utah, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Utah look for?

The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Utah are:

What cities in Utah are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities in Utah with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you

CQV Engineer

Stark Pharma Solutions Inc

West Valley City, UT • On-site

Contractor

Re-posted 13 days ago

Job description

Hi,

My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a CQV Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.

Job Title: CQV Engineer
Location: West Valley City, Utah
Duration: Long Term

Position Overview

We are seeking an experienced CQV Engineer to support Commissioning, Qualification, and Validation (CQV) activities within a pharmaceutical, biotechnology, or medical device manufacturing environment. This role will focus on ensuring that manufacturing equipment, utilities, facilities, and cleanroom systems are commissioned, qualified, and validated in compliance with GMP and regulatory requirements. The ideal candidate will have strong expertise in validation protocols, equipment qualification, regulatory compliance, and cross-functional collaboration to ensure reliable and compliant manufacturing operations.

Key Responsibilities

• Execute Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, utilities, facilities, and cleanroom systems.

• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

• Support commissioning and qualification of process equipment, HVAC systems, clean utilities, and facility infrastructure.

• Ensure compliance with GMP, FDA, ISPE, ASTM, and company quality standards throughout validation activities.

• Prepare validation documentation, technical reports, summary reports, and protocol deviations.

• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and Maintenance teams to support project execution.

• Assist with investigations, deviations, CAPA, change control, and risk assessments related to validation activities.

• Participate in equipment startup, factory acceptance testing (FAT), site acceptance testing (SAT), and commissioning activities.

• Maintain validation documentation and ensure all records comply with regulatory and quality system requirements.

• Support continuous improvement initiatives to enhance validation processes, compliance, and operational efficiency.

Required Qualifications

• Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering discipline.

• 3+ years of experience in Commissioning, Qualification, and Validation (CQV), Validation Engineering, or Equipment Qualification within pharmaceutical, biotechnology, or medical device manufacturing environments.

• Hands-on experience developing and executing IQ, OQ, and PQ protocols for manufacturing equipment, utilities, cleanrooms, and facility systems.

• Strong knowledge of GMP, FDA, ISPE, ASTM, validation lifecycle, and regulatory compliance requirements.

• Experience with equipment commissioning, facility qualification, utility validation, and cleanroom validation.

• Familiarity with validation documentation, protocol execution, deviation management, CAPA, change control, and risk assessment processes.

• Experience supporting FAT, SAT, equipment startup, and engineering project activities.

• Strong technical documentation, analytical, troubleshooting, and problem-solving skills.

• Excellent communication and cross-functional collaboration skills with the ability to work effectively in a regulated manufacturing environment.

• Experience working within pharmaceutical, biotechnology, or medical device manufacturing facilities is highly preferred.

• Knowledge of computerized systems validation (CSV), process validation, Lean Manufacturing, or Six Sigma methodologies is an added advantage.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/