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 is dedicated to building meaningful connections in the manufacturing community. We are collaborating with companies in Otsego seeking experienced Validation Engineers.
The Opportunity
We collaborate with manufacturing companies in the Otsego region seeking Validation Engineers. These employers partner with us because they want real insight into candidates—not just resumes. By joining our network, you gain access to roles worth considering.
Key Responsibilities
- Develop and execute validation protocols for manufacturing equipment, processes, and systems.
- Document all validation activities, including protocol development, execution, and summary reports.
- Identify and troubleshoot deviations from validation plans and implement corrective actions.
- Ensure compliance with relevant regulatory guidelines (e.g., FDA, GMP) and internal quality standards.
- Collaborate with R&D, Engineering, and Manufacturing teams to define validation strategies.
- Maintain and update validation documentation and databases.
- Participate in change control processes related to validated systems.
- Conduct revalidation activities as required by regulatory changes or system modifications.
Recommended Qualifications
- Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical) or a related scientific field.
- Proven experience in developing and executing validation protocols (IQ, OQ, PQ).
- Strong understanding of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., FDA, EMA).
- Experience with various manufacturing processes and equipment types.
- Proficiency in data analysis, statistical methods, and report writing.
- Familiarity with Quality Management Systems (QMS) and change control procedures.
Bonus Qualifications
- - Experience with statistical process control (SPC) software and methodologies
- - Familiarity with Good Automated Manufacturing Practice (GAMP) guidelines
- - Knowledge of lean manufacturing principles and their application in validation
- - Certification in relevant quality management systems (e.g., ASQ CQE)
Job Titles That Should Apply
Validation Engineer, Quality Engineer, QA Engineer, Quality Assurance Engineer, Test Engineer, Software Tester, Automation Tester, System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Product Validation Engineer, Manufacturing Validation Engineer, HPLC Validation Engineer, Analytical Validation Engineer, CSV Engineer, Computer System Validation Engineer, Validation Specialist, Test Automation Engineer, Performance Tester, Reliability Engineer
Why Pivot Group
The Pivot Group 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.
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. The Pivot Group 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:
GMP Data Resume Protocol Report Writing Offers Test Automation Access Support Modifications Lean Manufacturing Development Quality Management Assurance Analysis Compliance Salary Hiring Partnerships Corrective Actions Compensation Validation Reliability R Manufacturing Quality Assurance Writing Automation Databases Preparation Data Analysis Software Documentation Engineering Management
Salary Package:
$ 81,000.00 - 121,000.00 (US Dollar)