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Job Title
Sr Validation EngRequisition
JR000013123 Sr Validation Eng (Open)Location
Hobart, NY (Pharma) - USA036Additional Locations
Hobart, NYJob Description
Summary of Position
Implement and execute validation projects ranging from New Product Development, Equipment Validation, Process Validation, Packaging Validation and Cleaning Validation. Coordinate with cross functional resources in the execution of validation projects and ensure compliance with FDA, cGMP and any other appropriate regulations. Support manufacturing and packaging with new product introductions, process improvements, review and approval of Change Control documentation, review triages/exceptions related to deviation of manufacturing process, and provide technical support as required. Ensure product quality through robust testing and process monitoring including use of statistical process control techniques, Six Sigma tools and application of related pharmaceutical experience.
Essential Functions
Develop protocols using engineering experience and statistical process controls. Assist with multiple cross functional projects from development through release to production. Projects include new facilities startup, packaging line FAT and qualifications, and new product launch. Execute activities in support of the Validation Department priorities with the assistance of the department manager. Technical assistance during investigations of process/product issues. Support validation deviations of process/product or equipment. Execute validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols. Strong communication skills. Prepare and maintain validation records in accordance with department procedures to ensure compliance with current standards.
Minimum Requirements
Education:
BS in engineering discipline or technical field related to pharmaceutical manufacturing
Experience:
2-5 years of applied technical experience preferably with validation experience in pharmaceutical manufacturing and packaging.
Preferred Skills/Competencies:
Strong technical and mathematical aptitude. Training or certifications in regulatory and cGMP requirements is desired.
Other Skills/Competencies:
Strong computer literacy-MS office products, statistical analysis (Minitab) and database usage. Knowledge of statistical process controls is also required for equipment qualifications.
Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.