ZipRecruiter

Log In

1

Senior Computer System Validation Csv Jobs in Michigan

The Pivot Group

Validation Engineer - Walker Area

Walker, MI · On-site

$81K - $121K/yr

... CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Qualification Engineer, Validation Specialist, Quality Validation Engineer, Senior Validation Engineer, Lead ...

Biovire

Head of Validation

Brighton, MI · On-site

The Role The Manager, Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical oversight ...

Biovire

Head of Validation

Brighton, MI · On-site

The Role The Manager, Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical oversight ...

Biovire

Head of Validation

Brighton, MI · On-site

The Role The Manager, Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical oversight ...

BoehringerPRD

... computer system and computerized equipment validation within BIAH Operations, including program ... Understands content and compliance requirements for related CSV deliverables and uses this ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

next page

Showing results 1-20

All JobsComputer System Validation Csv JobsSenior Computer System Validation Csv JobsSenior Computer System Validation Csv Jobs in Michigan

Senior Computer System Validation Csv information

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

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

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges Senior Computer System Validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is a Senior Computer System Validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
What are the most commonly searched types of Computer System Validation Csv jobs in Michigan? The most popular types of Computer System Validation Csv jobs in Michigan are:
What are popular job titles related to Senior Computer System Validation Csv jobs in Michigan? For Senior Computer System Validation Csv jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Senior Computer System Validation Csv jobs in Michigan look for? The top searched job categories for Senior Computer System Validation Csv jobs in Michigan are:
What cities in Michigan are hiring for Senior Computer System Validation Csv jobs? Cities in Michigan with the most Senior Computer System Validation Csv job openings:
Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in Michigan as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.
Validation Engineer - Walker Area

Validation Engineer - Walker Area

The Pivot Group

Walker, MI • On-site

$81K - $121K/yr

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Job Description: Validation Engineer | Walker, MI Salary Range: $81,000 - $121,000 depending on experience Are you a forward-thinking professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is committed to fostering meaningful relationships in the manufacturing community. We partner with companies in Walker seeking skilled Validation Engineers. We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out. The Opportunity We are partnering with organizations in Walker that are seeking Validation Engineers. These companies are committed to building strong teams and are looking for professionals who can lead initiatives effectively. By connecting with The Pivot Group Network, you position yourself for roles that match your background and aspirations. Key Responsibilities
  • Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
  • Perform risk assessments and generate validation plans for new and modified systems.
  • Analyze data and generate validation reports summarizing results and conclusions.
  • Investigate deviations and non-conformances during validation activities, implementing corrective actions.
  • Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to ensure successful project execution.
  • Maintain validation documentation in accordance with regulatory requirements and internal procedures.
  • Provide technical expertise and guidance on validation principles and best practices.
Recommended Qualifications
  • Bachelor's degree in engineering or a related scientific discipline.
  • 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
  • Strong understanding of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
  • Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
  • Excellent technical writing and communication skills for authoring and reviewing validation documentation.
Bonus Qualifications
  • Experience with Computer System Validation (CSV) in an FDA-regulated environment.
  • Familiarity with GAMP 5 guidelines.
  • Knowledge of statistical methods for data analysis and sampling.
  • Certified Quality Engineer (CQE) or similar professional certification.
  • Experience with risk management tools and methodologies (e.g., FMEA, PHA).
Job Titles That Should Apply Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Qualification Engineer, Validation Specialist, Quality Validation Engineer, Senior Validation Engineer, Lead Validation Engineer, Principal Validation Engineer Why The Pivot Group Network The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic-they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. Learn more at https://www.thepivotgroup.org. If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out at https://www.thepivotgroup.org. The Pivot Group Network offers resources to support your search-market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement. Required Skills: • Technical Writing • Resume • Data • Offers • Support • Regulatory Requirements • Analysis • Salary • Hiring • Partnerships • Corrective Actions • Recruiting • Compensation • Validation • R • Manufacturing • Writing • Communication Skills • Risk Management • Regulations • Preparation • Data Analysis • Software • Documentation • Engineering • Communication • Management Salary Package: $ 81,000.00 - 121,000.00 (US Dollar)

Apply