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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