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Computer System Validation Csv Pharmaceutical Jobs in Nebraska

Troubleshoot server and computer-system problems. Monitors performance-related metrics (e.g ... Valid driver's license and acceptable driving record * Attendance: Regularly scheduled attendance ...

IT Systems Architect - 3292

Lincoln, NE · On-site

$211K/yr

Troubleshoot server and computer-system problems. Monitors performance-related metrics (e.g ... Valid driver's license and acceptable driving record * Attendance: Regularly scheduled attendance ...

Pharmacist - Registered

Omaha, NE · On-site

$53 - $63.50/hr

Orders products using a computer system. Coordinates proper maintenance and repairs for machinery and equipment. * May be required to act as Pharmacist-in-Charge during part of shift, when Pharmacy ...

Pharmacist - Registered

Omaha, NE · On-site

$55.50 - $66.75/hr

Orders products using a computer system. Coordinates proper maintenance and repairs for machinery and equipment. * May be required to act as Pharmacist-in-Charge during part of shift, when Pharmacy ...

Pharmacy Manager

Spalding, NE · On-site

$67 - $79/hr

... computer system purchased/adopted by the Pharmacy Department (may include clinical rules for CPOE ... Attend meetings with pharmaceutical representatives to discuss appropriate product use.* Ensure ...

Be Seen First

Utilize, update, and maintain data on Pharmacy computer system. * Operate cash register and ... Fill and package nursing home accounts under direction of pharmacist where applicable. * Process ...

Graduate Intern Pharmacist

Hastings, NE · On-site

$16.25 - $20.25/hr

Must hold a valid state intern license if required by the state of employment * Follows company ... Mixes pharmaceutical preparations, fills vials, bubble packs, and/or dads with the correct and ...

Showing results 21-40

Computer System Validation Csv Pharmaceutical information

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 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 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 popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Nebraska?

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

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

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

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

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

IT Systems Architect - 3292

Duncan Aviation

Lincoln, NE • On-site

$110 - $140/hr

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted 23 hours ago


Duncan Aviation rating

8.7

Company rating: 8.7 out of 10

Based on 57 frontline employees who took The Breakroom Quiz

10th of 67 rated aviation services


Job description

The IT Systems Architect designs and implements server and computer-system solutions—including allIBM Power Systems (IBM i / AS400) and their associated RPG environments—and maintains documentation. This position troubleshoots systems problems and monitors performance; interacts with vendors for server and computer-systems resources; reviews and recommends company hardware/software standards; and is responsible for server and computer-systems Disaster Recovery at assigned location(s). The IT Systems Architect may also be assigned networking responsibilities. The IT Systems Architect has a broad understanding of modern software-development practices and is able to effectively analyze and diagnose performance issues, as well as support all application development from a systems perspective.

Essential Job Functions
  1. Designs, plans, implements, and testsIBM Power Systems (IBM i / AS400)and computer-system solutions, including disaster recovery. Maintain documentation on systems. Schedules and monitors routine backups of server and computer systems.
  2. SecuresIBM Power Systems (IBM i / AS400)and computer systems by monitoring, controlling, and evaluating the environment. Troubleshoot server and computer-system problems. Monitors performance-related metrics (e.g., memory, disk usage, CPU utilization) and proactively address concerns. Ensure documentation is current.
  3. UpgradesIBM Power Systems (IBM i / AS400)and computer-systems hardware by evaluating, testing, and installing enhancements/updates. Review and recommend company standards for hardware, software, and license agreements. Maintains hardware/software inventory databases, ensuring proper licensing and usage. Interacts with approved vendors to acquire and manage server and computer-system resources.
  4. Designs and maintains automation within supported applications and systems to increase efficiency.
  5. Provides support and guidance to IT staff. Provides on-the-job training (OJT) and recognizes achievements of team members.
  6. Implement, secure, back up, maintain, and document networking-related systems as assigned.
  7. Coordinates with development teams to understand the impact of new or updated applications on system performance and recommend strategies to optimize workloads.
  8. Meets financial requirements by submitting information for budgets and monitoring expenses.
  9. Performs other duties as assigned.
Job Specific Requirements
  • Licenses/Certificates:Valid driver’s license and acceptable driving record
  • Attendance:Regularly scheduled attendance required
  • Physical:Routinely up to 50 lbs.; reads small print; repetitive motion; proficiency with a variety of PC hardware and software; tolerates working in confined spaces and heights above four feet; tolerates standing, walking, bending, kneeling, stooping, crouching, crawling, climbing, and sitting
  • Environmental:Tolerates working in extreme temperatures and noisy environments
Education and Experience
  • Associate’s degree in a computer-related field or equivalent required
  • Minimum five years of Information Technology experience, specificallyIBM Power System (IBM i / AS400), networking, Windows Servers, and MS Windows/Office required
  • Programming, scripting, and automation experience required using (SQL,RPG, CL, etc.)
Preferred Experience
  • Familiarity with basic software-development pipelines is strongly desired for performance monitoring, troubleshooting, etc.
  • Linux and orchestration-tools experience
  • Knowledgeable in at least one cloud architecture (e.g., AWS, Azure, or GCP)
  • Technical certifications (IBM, Microsoft, Cisco, etc.)
Available Benefits
  • Moving is expensive and hard work!Relocation Assistanceis available for those that qualify.
  • Duncan offers a comprehensiveBenefits Package(Medical, Dental, Vision, Vacation/Holiday) that is available to team members on day one.
  • Plan for your medical needs with aHealth Savings Account(employer and employee contributions).
  • Save for your future through our401(k) programwhere you can begin contributions within your first 45 days,50% match on first 6% contributed
  • Enjoy Duncan Aviation’sOn-Site Fitness & Health Clinicsat the MRO locations
  • Take advantage of a variety ofIn-House Trainingopportunities, or useTuition Assistanceto further your education.

Duncan Aviation is an Equal Opportunity and Aff… EOE Minorities/Females/Protected Veterans/Disabled

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