Validation Engineer - Wyoming Area

the-pivot-group-careers

Wyoming (MI)

On-site

USD 76,000 - 116,000

Full time

3 days ago
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Job summary

The Pivot Group Network in Wyoming, MI, is seeking a Validation Engineer to lead IQ/OQ/PQ activities for equipment, processes and software. You will perform risk assessments, generate validation plans, analyze data, and write reports to support regulatory compliance (FDA, ISO) and internal quality standards.

Collaborating with R&D, manufacturing, quality and regulatory affairs, you will ensure audit readiness and drive CAPAs and change controls.

Qualifications

  • Experience validating equipment, processes, and software across IQ/OQ/PQ.
  • Ability to perform risk assessments and generate validation plans.
  • Knowledge of FDA/ISO regulatory requirements and internal quality standards.

Responsibilities

  • Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
  • Perform risk assessments and generate validation plans.
  • Analyze validation data, write reports, and present findings.
  • Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
  • Investigate deviations and implement corrective and preventive actions (CAPAs) related to validation activities.
  • Support change control activities by assessing validation impact.
  • Maintain validation documentation and ensure audit readiness.
  • Collaborate with cross-functional teams including R&D, manufacturing, quality, and regulatory affairs.

Skills

Communication skills

Job description

Validation Engineer | Wyoming, MI

Salary Range: $76,000 - $116,000 depending on experience

Are you a dedicated 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 and supporting career growth. We partner with leading manufacturing companies in Wyoming, seeking experienced Validation Engineers to strengthen their teams.

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 Wyoming 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 equipment, processes, and software.
  • Perform risk assessments and generate validation plans.
  • Analyze validation data, write reports, and present findings.
  • Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
  • Investigate deviations and implement corrective and preventive actions (CAPAs) related to validation activities.
  • Support change control activities by assessing validation impact.
  • Maintain validation documentation and ensure audit readiness.
  • Collaborate with cross-functional teams including R&D, manufacturing, quality, and regulatory affairs.
Recommended Qualifications
  • Strong communication and problem-solving skills
Bonus Qualifications
  • Experience with statistical process control (SPC) and data analysis.
  • Familiarity with Six Sigma or Lean manufacturing principles.
  • Knowledge of cybersecurity principles as they apply to manufacturing systems.
  • Experience with risk management tools and methodologies (e.g., FMEAs).
  • Advanced proficiency in a programming language (e.g., Python, R) for data analysis and automation.
Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Validation Engineer, Equipment Validation Engineer, Process Validation Engineer, Cleaning Validation Engineer, Computer System Validation Engineer, Quality Engineer, QA Engineer, Validation Specialist, Validation Lead, Validation Manager, Software Validation Engineer, Test Engineer, Verification 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.

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