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Computer System Validation Csv Pharmaceutical Jobs in Decatur, MI

Bronson Healthcare

Inpatient Pharmacy Intern PRN

Kalamazoo, MI · On-site

$15.75 - $19.50/hr

Under the supervision of a licensed pharmacist, the Pharmacy Intern may: * Perform technical ... Entering medication orders into the computer system * Performing complex IV room tasks * Complete ...

Prime Staffing

Travel Inpatient Pharmacist

Elkhart, IN

$56.25 - $67.50/hr

Antibiotics*, Anticoagulation therapy*, Cad Cassette*, Cardiac dosing*, Carousel System ... Valid state license must be pending or candidate must be willing to participate in the Aya ...

Spruce Infotech

Pas-X System Owner

Kalamazoo, MI · On-site

- Minimum 5 years of hands-on experience with Werum PAS-X MES in a pharmaceutical or ... Engineering, Computer Science, Life Sciences, or related field. - Strong understanding of MES ...

Beacon Health System

Clinical Pharmacist

Elkhart, IN · On-site

$112.30K - $134.10K/yr

Join Beacon Health System: Where Your Expertise Enhances Patient Care At Beacon Health System, we ... Extended periods of computer screen time. * Some lifting and bending are required. Benefits * Sign ...

Beacon Health System

Certified Pharm Tech OP

Elkhart, IN · On-site

$17 - $20.75/hr

... the pharmacist per Board regulations. * Processes individual patient refill requests sent by email, phone, IVR system or computer. * Assist identified patients by referral to the Medication ...

Beacon Health System

Clinical Pharmacist

Elkhart, IN

$112.30K - $134.10K/yr

Join Beacon Health System: Where Your Expertise Enhances Patient Care At Beacon Health System, we ... Extended periods of computer screen time. * Some lifting and bending are required. Benefits * Sign ...

Beacon Health System

Certified Pharm Tech OP

Elkhart, IN · On-site

$17 - $20.75/hr

... the pharmacist per Board regulations. * Processes individual patient refill requests sent by email, phone, IVR system or computer. * Assist identified patients by referral to the Medication ...

Beacon Health System

Certified Pharm Tech OP

Elkhart, IN

$17.50 - $21.25/hr

... the pharmacist per Board regulations. * Processes individual patient refill requests sent by email, phone, IVR system or computer. * Assist identified patients by referral to the Medication ...

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Computer System Validation Csv Pharmaceutical information

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

As of May 30, 2026, the average hourly pay for computer system validation csv pharmaceutical in Decatur, MI is $50.13, according to ZipRecruiter salary data. Most workers in this role earn between $38.61 and $59.47 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) professional in the pharmaceutical industry, and why are they important?

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 are some 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 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 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 job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Decatur, MI look for? The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Decatur, MI are:
What cities near Decatur, MI are hiring for Computer System Validation Csv Pharmaceutical jobs? Cities near Decatur, MI with the most Computer System Validation Csv Pharmaceutical job openings:
Computer System Validation Csv Pharmaceutical jobs near you
5910 - CSV Engineer / Validation Engineer

5910 - CSV Engineer / Validation Engineer

Verista, Inc.

Kalamazoo, MI • On-site, Remote

Other

Posted 25 days ago

Job description

Validation Engineer Responsibilities:

  • Execute Computer System Validation activities for Electronic Batch Record (EBR) systems supporting aseptic fill operations in compliance with cGMP, 21 CFR Part 11, and EU Annex 11
  • Support development and review of validation deliverables including URS, FDS, risk assessments, and validation plans in alignment with GAMP 5 principles
  • Collaborate with Operations, Quality, Engineering, IT, and Automation teams to define system requirements, intended use, and validation scope
  • Participate in execution and documentation of validation testing (IQ, OQ, PQ), including deviation tracking and resolution support
  • Support validation of interfaces between PLC/SCADA systems and MES/EBR platforms to ensure data integrity and accurate batch execution
  • Maintain organized, inspection-ready validation documentation and support change control and periodic review activities for validated EBR systems

Requirements:

  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical field
  • 3+ years of hands-on Computer System Validation (CSV) experience in a regulated pharmaceutical or biotechnology environment, supporting MES and/or Electronic Batch Record (EBR) systems
  • Working knowledge of cGMP regulations, including 21 CFR Part 11 and EU Annex 11, and application of GAMP 5 principles across the system lifecycle
  • Experience supporting validation documentation and testing activities (URS, FDS, risk assessments, IQ/OQ/PQ) and managing deviations and change controls
  • Ability to collaborate effectively with cross-functional teams (Operations, Quality, Engineering, IT, Automation) and support system interfaces with PLC/SCADA-controlled equipment
  • Ability to travel/be on-site up to 25% of the time in Kalamazoo, MI. This role can be 75% remote.

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