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.
Responsibilities of the Senior Validation Engineer include:
Manage end to end, hands on, validation for products, processes, equipment and packaging
Supports all qualification tasks related to manufacturing equipment - IQ/OQ/PQ
Provide decisions on validation strategies and performance issues
Prepare, review and organize validation protocols and reports
Schedule and oversee validation tasks across all shifts
Support inspections and ensure cGMP compliance Qualifications for the Senior Validation Engineer include:
5+ years of experience in a pharmaceutical industry role, including experience in validation, tech transfer and leadership
Equipment and Cleaning validation (preferred), with knowledge of FDA regulations and guidelines.
Proficiency in validation tools and software, including Office 365, Oracle, QMS, statistical/process validation methods (preferred)
Strong technical writing, verbal and written communication skills
Ability to manage multiple tasks, work independently, and thrive in a fast-paced environment with changing priorities
Engineering or Science related 4-year degree required Compensation for the Senior Validation Engineer include:
Salary Range: $85,000 - $95,000 Depending on experience
Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave if required by law, and Holidays
This job opens for applications on 3/21/2025 . Applications for this job will be accepted for at least 30 days from the posting date.
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
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