Validation Engineer - Rockford Area
$77k - $117kThe Pivot Group
Job Description: Validation Engineer | Rockford, MI Salary Range: $77,000 - $117,000 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 Rockford 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 partnering with organizations in Rockford 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
• Minitab
• Resume
• Data
• Offers
• Lean Six Sigma
• Support
• Root Cause Analysis
• Six Sigma
• ROOT
• Regulatory Requirements
• Analysis
• Compliance
• Salary
• Hiring
• Partnerships
• Corrective Actions
• Recruiting
• Compensation
• Validation
• Manufacturing
• Automation
• Programming
• Regulations
• Preparation
• Data Analysis
• Software
• Documentation
• Engineering
• Project Management
• Management
Salary Package:
$ 77,000.00 - 117,000.00 (US Dollar)
- Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
- Perform risk assessments and generate validation plans in compliance with regulatory requirements (e.g., FDA, ISO).
- Analyze validation data, write comprehensive validation reports, and present findings to cross-functional teams.
- Investigate deviations and out-of-specification results during validation activities, implementing corrective actions.
- Collaborate with engineering, quality, and production teams to ensure successful technology transfers and new product introductions.
- Maintain and update validation master plans, procedures, and documentation to reflect current regulatory standards and best practices.
- Support internal and external audits by providing validation documentation and expertise.
- Bachelor's degree in engineering or a related scientific discipline.
- 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
- Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485).
- Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
- Demonstrated ability to perform root cause analysis and implement corrective actions for validation deviations.
- Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
- Familiarity with automation systems and software (e.g., SCADA, DCS, PLC programming).
- Certification in Lean Six Sigma (Green Belt or Black Belt).
- Project management experience or certification (e.g., PMP, CAPM).
- Working knowledge of cybersecurity principles in manufacturing environments.
• Minitab
• Resume
• Data
• Offers
• Lean Six Sigma
• Support
• Root Cause Analysis
• Six Sigma
• ROOT
• Regulatory Requirements
• Analysis
• Compliance
• Salary
• Hiring
• Partnerships
• Corrective Actions
• Recruiting
• Compensation
• Validation
• Manufacturing
• Automation
• Programming
• Regulations
• Preparation
• Data Analysis
• Software
• Documentation
• Engineering
• Project Management
• Management
Salary Package:
$ 77,000.00 - 117,000.00 (US Dollar)
Vacancy posted 4 days ago
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