Validation Engineer Supervisor Position Available In Passaic, New Jersey

Job Title:

Packaging Engineer Job Description The Packaging Engineer ensures operational compliance with cGMP’s and customer-required protocols during packaging processes. This role is responsible for facilitating and coordinating all activities of the Validation Department, ensuring continuous compliance with regulatory and company rules. Responsibilities Develop and implement updates to the Master Validation Plan for the packaging facility alongside Engineering Staff, QA Director/QA Manager, and Compliance Manager. Lead and coordinate activities for all associates in the department. Establish, document, and manage the Bioburden Monitoring, Compressed Air Point of Use, and Calibration programs. Develop and document change controls, validation plans, qualification protocols, and associated reports and documents. Maintain and update a documented Cleaning Validation program. Maintain Validation Documentation/Control plan. Review and update Standard Operating Procedures applicable to this job function. Schedule, conduct, and document external audits. Coordinate all validation processes regarding validation programs and schedules with customers in collaboration with Business Operations, Scheduling, Engineering, and QA. Interact with Engineering, Technical Service, QA, Operations, Sales, and Business Ops to fulfill job responsibilities. Review change controls for equipment and validation impact. Review and approve calibration, qualification, and validation documentation for accuracy, completeness, and compliance. Assist in the preparation and execution of deviations, complaints, and non-conformance investigations. Assist with Annual Product Reviews. Essential Skills Experience in packaging, ideally from a smaller company for diversified experience. Aptitude in technical validation skills and operational communication/management. Leadership skills and qualities. Understanding of Quality Assurance and Validation technical skills. Ability to serve as a liaison with internal QA and business operations. Experience in documentation with reference to internal formats. Additional Skills & Qualifications Ability to work independently and as part of a team. Exceptional communication (written and verbal) and interpersonal skills. High level of multi-tasking ability and proven organizational skills. Computer (PC), data collection, and analysis skills. Comprehension of packaging equipment concepts for validation purposes. Detail-oriented. Minimum 3-4 years pharmaceutical/packaging experience or equivalent. Proficiency in English, both written and verbal. Proven abilities in the development, execution, and final review of IQ/OQ and PQ/PV validation protocols. Experience in calibration, testing, and documentation requirements. Ability to communicate effectively with customers regarding all aspects of validation and calibration. Bachelor of Science Degree in Engineering required. Ability to lead people and execute department objectives on time and on budget. Physical ability to move about office areas and production floors, lift up to 25 pounds, and travel for audits. Work Environment This position requires working fully onsite five days a week. The work involves moving about the office and production floor, interacting with employees at all levels, and traveling for supplier audits and factory acceptance tests. The role necessitates staying stationary up to 80% of the time and lifting up to 25 pounds.