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Computer System Validation Csv Pharmaceutical Jobs in Michigan

Stellantis

AI Validation Engineer

Auburn Hills, MI · On-site

We are seeking a Senior AI Validation Engineer to design and implement testing strategies ... system integration disciplines. Basic Qualifications: * Bachelor's degree in computer science ...

Agile Global Solutions, Inc

CAD Designer

Detroit, MI · On-site

$24.75 - $34/hr

Light Gauge Steel (CFS) framing systems * Structural detailing and shop drawings * Building ... Generate fabrication data, Bills of Materials (BOMs), and CSV files for automated roll-forming ...

BoehringerPRD

Description This position manages all equipment, process, systems and product related validation activities, except GXP related computerized systems for both Pharmaceuticals and Vaccines at the site

Pfizer

Senior Validation Engineer

Rochester, MI · On-site

$82K - $137K/yr

Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems * Experience with sterile products and medical devices

Pfizer, Inc.

Senior Validation Engineer

Rochester, MI · On-site

$82K - $137K/yr

Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems * Experience with sterile products and medical devices

Pfizer

Senior Validation Engineer

Rochester, MI · On-site

$82K - $137K/yr

Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems * Experience with sterile products and medical devices

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

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.
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Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in Michigan as of August 2026, with employment types broken down into 8% Internship, 77% Full Time, and 15% Part Time. Highlights an 92% In-person, and 8% Remote job distribution.

System Development Engineer- Medical Device

Tek Labs Inc

Zeeland, MI • On-site

Other

Posted 3 days ago

New

Job description

Title: System Development Engineer- Medical Device
Location: Zeeland, MI (Onsite)
Duration: Long-Term Contract

Key Requirements:

  • Bachelor’s degree in Electrical Engineering, Computer Engineering, Software Engineering, or a related field with 5–10 years of Systems Engineering experience.
  • Experience developing system requirements, system architecture, interface requirements, and end-to-end requirements traceability.
  • Hands-on experience with system validation, System FMEA, and systems engineering processes.
  • Strong knowledge of ISO 26262 (ASIL), ASPICE, and embedded software/system development.

This role involves leading system-level development for cabin monitoring, digital vision, connectivity, and other advanced automotive technologies, including system architecture, requirements management, traceability, and system validation.

Apply