Validation Engineer - Allendale Area

We are collaborating with multiple companies in Allendale 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.

• →Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• →Perform risk assessments and generate validation plans.
• →Analyze data and write comprehensive validation reports summarizing results and conclusions.
• →Investigate and resolve validation deviations and non-conformances.
• →Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• →Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure successful validation activities.
• →Support internal and external audits by providing validation documentation and expertise.

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years of experience in validation within a regulated manufacturing environment (e.g., Pharma, Biotech, Medical Devices).
• Proficient in creating and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of cGMP, FDA regulations (e.g., 21 CFR Part 11, 210, 211, 820), and industry standards (e.g., GAMP 5, ICH Q7, Q9, Q10).
• Experience with Quality Management Systems (QMS) and deviation/CAPA management processes.

• Experience with statistical process control (SPC) and data analysis tools (e.g., MiniTab, JMP).
• Familiarity with automation systems and software (e.g., SCADA, PLC, MES).
• Knowledge of cybersecurity principles as they apply to manufacturing systems.
• Certified Quality Engineer (CQE) or similar professional certification.
• Experience with risk management frameworks (e.g., FMEA, PHA).

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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 https://www.thepivotgroup.org.

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 https://www.thepivotgroup.org. 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.