Want to work in a flexible, High Performance Work System?
It’s an exciting time to be part of the Nutrition & Biosciences(now part of IFF) family. We are a global leader in the Probiotic industry. To meet ongoing product demands, our Madison, Wisconsin facility is hiring for a QA Pharma Compliance Senior Validation Engineer!
As a QA Pharma Compliance Validation Engineer you will design, plan, and support in the commissioning and validation of equipment and processes used in the manufacture of bio-ingredients to ensure that the processes employed are demonstrated to be efficient and adequate and the manufactured goods meet all purity, safety and quality requirements.
This individual will be a part of a team which will implement, support and maintain cGMP’s and the Quality Management System at the Madison site as needed to assure the compliance of products produced by IFF with all internal, customer and regulatory requirements.
The essential functions of this position include, but are not limited to, the following:
• Write, review, and approve validation master plans, validation plans, SOPs and other validation documentation. Assist with risk analysis for process
• Prepare and plan validation studies in support of method development and ongoing validation. Coordinate validation study testing with affected departments and personnel.
• Perform system and component level impact assessments for equipment.
• Prepare protocols for validation/qualification of methods and related equipment; prepare detailed reports of testing and provide review of procedures and protocols.
• Assist in training Process Operators, QC analysts, and other staff in regards to validation procedures and protocols.
• Coordinate the implementation and scheduling of validation testing with affected departments and personnel.
• Write, review and approve validation deviations. Identify deviations from established product, process, and/or test standards and provide recommendations for resolving deviations in support of validation.
• Provide expertise and participate in management of change on validation impact in regard to new and modified equipment, methods, and processes.
• Perform validation assessments and testing as needed per approved changes and modifications to the plant; evaluate impact of change on status of validation and write technical assessments in support of validation.
• Work with outside vendors in support of vendor equipment commissioning and qualifications; initiate and review vendor documentation before and after execution.
• Participate in capital projects as a design team member to ensure proper selection of new equipment and methods in support of validation.
• Ensure adherence to IFF’s Quality and Environmental Policies and Procedures.
• Comply with all company policies, including maintaining a drug free work place.
• Support an environment of continuous improvement within the assigned area and develop awareness for product and production quality.
• Must have a Bachelor’s degree in Microbiology, Biology, Food Science, Process Engineering, or related field and a minimum of 2 years of experience in Validation.
• Must have experience adhering to cGMPs and other regulatory compliance procedures. Experience within dietary supplement or pharmaceutical environment .
• Knowledge of the practical application of engineering science and technology including techniques, procedures and equipment required for design and production specifications; Experience with systems analysis to determine how a system should work and how changes in conditions, operations and the environment will affect outcomes is required.
• Must possess effective communication, interpersonal, team-building skills at various levels with other departments.
• Must possess strong organizational and time-management skills and the ability to work independently.