Validation Engineer - Paw Paw Area
$80k - $120kThe Pivot Group
Job Description: Validation Engineer | Paw Paw, MI Salary Range: $80,000 - $120,000 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 Paw Paw, 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 working with companies in Paw Paw 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
• Minitab
• Resume
• Data
• Offers
• Life Sciences
• Test Automation
• Support
• Mitigation
• Assurance
• Analysis
• Compliance
• Salary
• Hiring
• Partnerships
• Corrective Actions
• Recruiting
• Compensation
• Risk Assessment
• Validation
• Manufacturing
• Quality Assurance
• Automation
• Risk Management
• Regulations
• Preparation
• Data Analysis
• Software
• Engineering
• Management
Salary Package:
$ 80,000.00 - 120,000.00 (US Dollar)
- Develop and execute validation protocols for equipment, processes, and software.
- Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
- Analyze data and generate comprehensive validation reports.
- Conduct risk assessments and develop mitigation strategies for manufacturing processes.
- Ensure compliance with cGMP, FDA regulations, and industry standards.
- Troubleshoot validation discrepancies and implement corrective actions.
- Collaborate with cross-functional teams on new product introductions and process improvements.
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
- Proven experience with GxP regulations, FDA 21 CFR Part 11, Part 820, and relevant industry standards (e.g., ISO 13485).
- Demonstrated expertise in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
- Strong understanding of statistical methods for data analysis and validation.
- Experience with risk assessment tools and methodologies (e.g., FMEA).
- Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
- Familiarity with automation systems and software validation in a manufacturing context (e.g., SCADA, DCS, PLCs).
- Certified Quality Engineer (CQE) or similar professional certification.
- Knowledge of cybersecurity principles as they apply to validated systems.
- Experience with risk management methodologies (e.g., FMEA, PHA) in a validation context.
• Minitab
• Resume
• Data
• Offers
• Life Sciences
• Test Automation
• Support
• Mitigation
• Assurance
• Analysis
• Compliance
• Salary
• Hiring
• Partnerships
• Corrective Actions
• Recruiting
• Compensation
• Risk Assessment
• Validation
• Manufacturing
• Quality Assurance
• Automation
• Risk Management
• Regulations
• Preparation
• Data Analysis
• Software
• Engineering
• Management
Salary Package:
$ 80,000.00 - 120,000.00 (US Dollar)
Vacancy posted 2 days ago
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