Validation Engineer

We are actively seeking a dedicated Validation Engineer to join our team in Jersey City, NJ. This is an exceptional long-term contract opportunity for an individual passionate about ensuring the highest standards of quality and compliance in the pharmaceutical and life sciences sector. As a Validation Engineer, you will play a crucial role in supporting our Good Manufacturing Practice (GMP) initiatives and contributing to the successful qualification of critical equipment.

Key Responsibilities

• Provide comprehensive support for GMP validation and equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop, meticulously execute, and meticulously review validation protocols, ensuring all documentation is accurate and compliant with industry standards.
• Prepare detailed validation reports, summarizing findings and ensuring all processes meet regulatory requirements.
• Actively participate in investigations related to validation deviations, identifying root causes and implementing corrective actions.
• Ensure unwavering compliance with current Good Manufacturing Practices (cGMP) throughout all validation processes.
• Apply expert knowledge of GAMP (Good Automated Manufacturing Practice), 21 CFR Part 11, Good Documentation Practices (GDP), and data integrity principles.

Requirements

• Bachelor’s degree in a relevant scientific or engineering discipline.
• A minimum of 1 year of hands-on cGMP experience within the Pharmaceutical or Life Sciences industries.
• Demonstrated experience with cell therapy equipment qualification is considered a significant advantage.
• Exceptional communication skills, both written and verbal, for effective collaboration and documentation.
• Strong organizational abilities, capable of managing multiple tasks and projects simultaneously.
• Proven aptitude for multitasking and working effectively in a fast-paced, regulated environment.

What We Offer

• An engaging long-term contract opportunity to advance your career in a vital role.
• The chance to work within a dynamic team focused on innovation and quality in healthcare.
• Exposure to cutting-edge validation processes and technologies.
• A supportive work environment that values professional growth and development.
• The opportunity to make a tangible impact on product quality and patient safety.