Validation Engineer - Wayland Area
$77k - $117kThe Pivot Group
Job Description: Validation Engineer | Wayland, MI Salary Range: $77,000 - $117,000 depending on experience Are you a detail-oriented professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to fostering meaningful relationships and supporting career advancement. We are collaborating with leading companies in Wayland 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 collaborating with multiple companies in Wayland seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals. Key Responsibilities
• GMP
• Technical Writing
• Resume
• Data
• Offers
• Access
• Support
• Regulatory Requirements
• Analysis
• Compliance
• Data Integrity
• Salary
• Hiring
• Partnerships
• Corrective Actions
• Recruiting
• Compensation
• Validation
• R
• Manufacturing
• Writing
• Automation
• Programming
• Regulations
• Preparation
• Data Analysis
• Software
• Engineering
• SQL
• Python
Salary Package:
$ 77,000.00 - 117,000.00 (US Dollar)
- Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
- Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
- Analyze data and author comprehensive validation reports, including deviations and corrective actions.
- Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to define validation strategies.
- Maintain validation master plans and ensure all validation activities are documented and archived properly.
- Investigate and troubleshoot validation failures, implementing effective solutions and preventative measures.
- Stay current with industry standards and regulatory guidelines related to validation practices.
- 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, FDA regulations (e.g., 21 CFR Part 820, Part 211), and ISO standards (e.g., ISO 13485).
- Proven experience with validation lifecycle activities including IQ, OQ, PQ for equipment, processes, and software.
- Excellent technical writing skills for creating and executing validation protocols and reports.
- Experience with Computer System Validation (CSV) in an FDA-regulated environment.
- Familiarity with data integrity principles and ALCOA+.
- Knowledge of GAMP 5 guidelines.
- Experience with risk-based validation methodologies.
- Scripting or programming experience (e.g., Python, SQL) for data analysis or automation.
• GMP
• Technical Writing
• Resume
• Data
• Offers
• Access
• Support
• Regulatory Requirements
• Analysis
• Compliance
• Data Integrity
• Salary
• Hiring
• Partnerships
• Corrective Actions
• Recruiting
• Compensation
• Validation
• R
• Manufacturing
• Writing
• Automation
• Programming
• Regulations
• Preparation
• Data Analysis
• Software
• Engineering
• SQL
• Python
Salary Package:
$ 77,000.00 - 117,000.00 (US Dollar)
Vacancy posted 4 days ago
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