<p>Piper Companies is seeking a Senior Validation Engineer to join a leading pharmaceutical manufacturing company located in Long Island, NY. The Senior Validation Engineer will ensure compliance by developing and executing testing protocols for equipment, processes, and utilities in a pharmaceutical cGMP environment.</p> <p>Responsibilities of the Senior Validation Engineer include:</p> <ul> <li>Manage end to end, hands on, validation for products, processes, equipment and packaging </li><li>Supports all qualification tasks related to manufacturing equipment - IQ/OQ/PQ </li><li>Provide decisions on validation strategies and performance issues </li><li>Prepare, review and organize validation protocols and reports </li><li>Schedule and oversee validation tasks across all shifts </li><li>Support inspections and ensure cGMP compliance </li></ul> <p>Qualifications for the Senior Validation Engineer include:</p> <ul> <li>5+ years of experience in a pharmaceutical industry role, including experience in validation, tech transfer and leadership </li><li>Equipment and Cleaning validation (preferred), with knowledge of FDA regulations and guidelines. </li><li>Proficiency in validation tools and software, including Office 365, Oracle, QMS, statistical/process validation methods (preferred) </li><li>Strong technical writing, verbal and written communication skills </li><li>Ability to manage multiple tasks, work independently, and thrive in a fast-paced environment with changing priorities </li><li>Engineering or Science related 4-year degree required </li></ul> <p>Compensation for the Senior Validation Engineer include:</p> <ul> <li>Salary Range: $85,000 - $95,000 Depending on experience </li><li>Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave if required by law, and Holidays </li></ul> <p>This job opens for applications on 3/7/2025. Applications for this job will be accepted for at least 30 days from the posting date.</p> <p>Keywords: commissioning, qualification, decommissioning, production, validation standards, validation criteria, procedures, protocol, validation test equipment, detail-oriented, quality assurance, innovation, documentation, communication, collaboration, risk management, time management, GMP, problem solving, medical device, hardware, adaptability, technical writing, project management, FDA, Oracle, QMS, statistical tools , biological sciences, engineering, tests, instruments, quality director, quality engineer, supplier quality engineer, validation specialist</p> <p>#LI-KT1 #LI-ONSITE</p>