Validation Engineer – Charlotte Area

The Pivot Group Careers

Charlotte (MI)

On-site

USD 81,000 - 121,000

Full time

13 days ago

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Job summary

The Pivot Group Network is seeking a Validation Engineer to support manufacturers around Charlotte, MI. The role focuses on developing and executing validation protocols for equipment, processes, and software systems in regulated environments.

Candidates should have a bachelor’s degree in engineering or a related field, strong statistical analysis skills, and experience with GMP/ISO or FDA requirements. This opportunity emphasizes collaboration across production, engineering, and quality teams.

Qualifications

  • Experience with statistical analysis and test data interpretation.
  • Bachelor’s degree in engineering or a related technical field.
  • Experience writing and executing validation protocols in a manufacturing setting.
  • Familiarity with quality standards such as GMP, ISO 9001, or FDA requirements.
  • Strong technical writing and documentation skills.
  • Ability to read schematics, specifications, and process diagrams.

Responsibilities

  • Review and update standard operating procedures tied to validated processes.
  • Write and execute validation protocols for equipment, processes, and software systems.
  • Perform installation, operational, and performance qualification activities.
  • Collect and analyze test data and document results in validation reports.
  • Investigate failures and deviations and support root cause analysis.
  • Maintain validation documentation to meet regulatory and quality standards.
  • Coordinate validation schedules with production, engineering, and quality teams.
  • Support change control by assessing impact and revalidating as needed.

Skills

Statistical analysis
Technical writing
Quality systems
Documentation
Process validation

Education

Bachelor’s degree in engineering or related technical field

Tools

Minitab
Python

Job description

Job Description:

Validation Engineer | Charlotte, MI

Salary Range: $81,000 – $121,000 depending on experience

Are you a dynamic leader with a passion for excelling as a validation engineer? The Pivot Group Network, a Michigan manufacturing-focused recruiting group, is dedicated to building meaningful connections and supporting community growth. We collaborate with leading companies in the Charlotte area seeking experienced Validation Engineers to drive results.

We are building our network of talent in this field across Michigan’s manufacturing regions. 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.

This posting covers Validation Engineer opportunities with manufacturers based in and around Charlotte in Eaton County, within about 45 minutes of the city, including Eaton Rapids, Potterville, Olivet, and Bellevue.

The Opportunity

We partner with manufacturers across the Charlotte area seeking Validation Engineers who want more than a lateral move. These companies hire intentionally, and we connect them with professionals ready for roles that fit.

Usual Responsibilities

  • Review and update standard operating procedures tied to validated processes.
  • Write and execute validation protocols for equipment, processes, and software systems.
  • Perform installation, operational, and performance qualification activities.
  • Collect and analyze test data and document results in validation reports.
  • Investigate failures and deviations and support root cause analysis.
  • Maintain validation documentation to meet regulatory and quality standards.
  • Coordinate validation schedules with production, engineering, and quality teams.
  • Support change control by assessing impact and revalidating as needed.

Recommended Qualifications

  • Experience with statistical analysis and test data interpretation.
  • Bachelor’s degree in engineering or a related technical field.
  • Experience writing and executing validation protocols in a manufacturing setting.
  • Familiarity with quality standards such as GMP, ISO 9001, or FDA requirements.
  • Strong technical writing and documentation skills.
  • Ability to read schematics, specifications, and process diagrams.

Bonus Qualifications

  • Experience with automated test equipment and data acquisition systems.
  • Knowledge of lean or Six Sigma methods.
  • Experience with computer system validation and 21 CFR Part 11.
  • Certification in quality or validation such as CQE or CSQE.
  • Background in medical device, pharmaceutical, or automotive manufacturing.

Job Titles That Should Apply

Test Engineer, Computer System Validation Specialist, Regulatory Affairs Specialist, Quality Assurance Engineer, Quality Engineer, Process Validation Engineer, Equipment Qualification Engineer, Compliance Engineer, Manufacturing Quality Engineer

Work Authorization

Applicants must be authorized to work in the U.S. without current or future visa sponsorship. Visa sponsorship is not available.

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.

Required Skills:

Minitab Resume Data Offers Life Sciences Test Automation Access Support Six Sigma Assurance Analysis Compliance Salary Hiring Partnerships Recruiting Compensation Validation R Manufacturing Quality Assurance Automation Programming Regulations Preparation Data Analysis Software Documentation Engineering Python

Salary Package:

$ 81,000.00 – 121,000.00 (US Dollar)

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