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Computer System Validation Csv Pharmaceutical Jobs in Ridott, IL

Beloit Health System

Pharmacy Technician

Beloit, WI · On-site

$17 - $20.75/hr

Beloit Health System is looking to add a Pharmacy Technician to our Team! * Shift: 1st & 2nd ... Under the supervision of a licensed pharmacist, the Pharmacy Technician assists in the preparation ...

Beloit Health System

Pharmacy Technician

Beloit, WI · On-site

$19.25 - $26.95/hr

Beloit Health System is looking to add a Pharmacy Technician to our Team! Shift: 1st & 2nd ... Under the supervision of a licensed pharmacist, the Pharmacy Technician assists in the preparation ...

Beloit Health System

Pharmacy Technician

Beloit, WI · On-site

$19.25 - $26.95/hr

Beloit Health System is looking to add a Pharmacy Technician to our Team! * Shift: 1st & 2nd ... Under the supervision of a licensed pharmacist, the Pharmacy Technician assists in the preparation ...

PCI Pharma Services

Validation Analyst 1

Rockford, IL · On-site

... system project launch and maintaining existing validated processes / programs at multiple sites as ... Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate ...

PCI Pharma Services

Validation Analyst 1

Rockford, IL · On-site

... system project launch and maintaining existing validated processes / programs at multiple sites as ... Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate ...

Costco Wholesale Corporation

Pharmacy Manager

Loves Park, IL · On-site

$62.25 - $73.50/hr

Orders products using a computer system. Coordinates proper maintenance and repairs for machinery ... Acts as Pharmacist-In-Charge, as point of contact for regulatory, legal, third party insurance ...

Costco Wholesale Corporation

Pharmacy Manager

Loves Park, IL · On-site

$62.25 - $73.50/hr

Orders products using a computer system. Coordinates proper maintenance and repairs for machinery ... Acts as Pharmacist-In-Charge, as point of contact for regulatory, legal, third party insurance ...

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Computer System Validation Csv Pharmaceutical information

See Ridott, IL salary details

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$51

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How much do computer system validation csv pharmaceutical jobs pay per hour?

As of Sep 3, 2026, the average hourly pay for computer system validation csv pharmaceutical in Ridott, IL is $51.56, according to ZipRecruiter salary data. Most workers in this role earn between $39.71 and $61.15 per hour, depending on experience, location, and employer.

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 cities near Ridott, IL are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities near Ridott, IL with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you

Manager, Facilities & Software Validations

PCI Pharma Services

Rockford, IL • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 20 days ago

Key responsibilities

  • Coordinate and manage validation efforts related to Facility/Utility and Computer Equipment at multiple facilities.

  • Review and approve validation and change control documentation, including protocols, reports, and work practices.

  • Plan, execute, and oversee validation of facilities, cleanrooms, and utilities, ensuring compliance with regulatory standards.

PCI Pharma Services rating

6.3

Company rating: 6.3 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

491st of 545 rated manufacturers

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
The Facilities and Software Validations Manager is responsible for coordinating and managing all validation efforts related to Facility/Utility and Computer Equipment at multiple facilities. The Validations Manager is responsible for designing, maintaining and continually improving the validation system. The Validations Manager is responsible for implementation and ongoing improvements of the validation policies, protocols and testing. Provide technical expertise and guidance to customers, the Validations department as well as working with the range of internal departments. Coordinate with other departments to communicate validations and provide resources to implement protocol executions. The Facilities and Software Validations Manager assures customer requirements are accurately incorporated into PCI systems and assures validation protocols adhere to cGMP requirements.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
  • Oversees and manages Validations Supervisor(s), engineers, and, as required, other Validations personnel Manage, identify, hire, and develop staff.
  • Create and maintain employee and organizational development.
  • Oversee proper training, goal setting and effective organizing and assigning of work.
  • Reviews and approves validation and change control documentation, including protocols, summary reports, etc., for validation activities, process parameters, and validation work practices.
  • Manage and develop facility, utility, and computer validations program that is in compliance with regulatory and customer expectations, which includes developing and maintaining Validation Master Plan and policy and work practices. Design, maintain and continually improving the validation system in line with current national and international standards.
  • Assist with validation harmonization among sites across the PCI Pharma Services organization.
  • Provide Validation technical expertise and guidance to the groups within the organization and customers on validation policies and procedures and the implementation of those within the Operations and Quality Assurance (QA) functional areas.
  • Develops and administers budgets, schedules and performance requirements and evaluations.
  • Plan, execute, and oversee validation of facilities, cleanrooms, and utilities (HVAC, compressed air, water systems, gases).
  • Develop and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and validation summary reports.
  • Ensure facility changes are evaluated through change control and revalidation activities as required.
  • Support environmental monitoring programs and facility qualification strategies.
  • Lead CSV activities in accordance with GAMP 5, FDA, and ISO requirements.
  • Define validation strategies based on system impact, intended use, and risk.
  • Review and approve system lifecycle documentation (URS, FS, DS, risk assessments, test scripts, traceability matrices).
  • Ensure data integrity principles (ALCOA+) are applied across computerized systems.
  • Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various product quality systems such as Change Control and CAPA.
  • Participates, present and provide rationale for the validation program during periodic audits and regulatory inspection and customer visits/conference calls as required.
  • This position may require overtime and/or weekend work. Performs other duties as assigned by Director.the

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Required:
  • Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
  • Minimum of 6-8 years of experience in facilities, utilities, and computer system validation in a regulated industry (medical devices, pharmaceutical, or biotechnology).
  • Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
  • Prior experience supervising or leading validation personnel preferred.
  • Strong understanding of validation lifecycle activities (URS, risk assessments, IQ, OQ, PQ, and validation reports).
  • In-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology.
  • Working knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11).
  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
  • Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
  • High Standard of Report Writing

Preferred:
  • Ability to effectively present information to various people as the job requires.
  • Ability to identify and resolve problems in a timely manner.
  • Ability to display original thinking and creativity.
  • Ability to show success in managing employees.
  • Ability to demonstrate attention to detail.
  • Ability to set and achieve challenging goals.

The hiring rate for this position is $108,960.00 -$122,580.00 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
#LI-DT1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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