Validation Engineer - Otsego Area

Job Description:

Validation Engineer | Otsego, MI

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

Are you a skilled professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to building meaningful connections in the manufacturing community. We are collaborating with companies in Otsego seeking experienced 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 working with companies in Otsego that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

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 validation data, write reports, and ensure compliance with regulatory requirements (e.g., FDA, ISO).
• Investigate deviations and out-of-specification results during validation activities, implementing corrective actions.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to integrate validation into project lifecycles.
• Maintain and update validation documentation, including procedures, master plans, and executed protocols.
• Support internal and external audits by providing validation expertise and documentation.

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 (e.g., 21 CFR Part 820, Part 210/211, Part 11).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Excellent technical writing and communication skills for authoring 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.
• Experience with risk-based validation approaches.
• Scripting or programming experience (e.g., Python, R) for data analysis or automation.

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Test Automation Engineer, Quality Assurance Engineer, QA Validation Engineer, Regulatory Affairs Specialist, Compliance Engineer, Validation Specialist, Validation Lead, Validation Manager

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 ;br>
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 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
Test Automation
Support
Regulatory Requirements
Assurance
Analysis
Compliance
Salary
Hiring
Partnerships
Corrective Actions
Recruiting
Compensation
Validation
R
Manufacturing
Quality Assurance
Writing
Automation
Communication Skills
Programming
Regulations
Preparation
Data Analysis
Software
Documentation
Engineering
Python
Communication

Salary Package:
$ 81,000.00 - 121,000.00 (US Dollar)