QA Pharma Compliance Validation Engineer – Nutrition and Health
To design and plan validation protocols for equipment, processes and test methods used in the manufacture of bio-ingredients to ensure that (1) the processes employed are demonstrated to be efficient and adequate and (2) the manufactured goods meet all purity, safety and quality requirements with regards to internal, external (customer), and regulatory requirements.This individual will be a part of a team which will implement, support and maintain pharmaceutical cGMP???s and the Quality Management System at the Madison site as needed to assure the compliance of products produced by DuPont with all internal, customer and regulatory requirements. This position reports directly to the QA Manufacturing Lead – Pharma Project Manager for the Madison site and is directly responsible for validation at the Madison site. ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential functions of this position include, but are not limited to, the following:
Provide insight and individual contribution in obtaining and maintaining compliance with ICH Q7 guidance for active pharmaceutical ingredients. Troubleshoot method and process issues in assurance of successful validation. Recommend technical design/changes to improve efficiency, quality or performance in support of validation.Write, review, and approve validation master plans, validation plans, SOP???s and other validation documentation.Perform risk analysis for process (i.e. FMEA).Prepare protocols for validation/qualification of existing processes/methods and equipment; prepare detailed reports of validation and qualification testing and provide review of procedures and protocols.Prepare and plan validation studies in support of ongoing validation. Coordinate validation study testing with affected departments and personnel.Assist in training Process Operators, QC analysts, and other staff in regards to validation procedures and protocols.Serve as a backup to the change control coordinator; provide expertise on validation impact in regards to new and modified equipment and processes.Coordinate the implementation and scheduling of validation testing with affected departments and personnel.Perform system and component level impact assessments for manufacturing equipment.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.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 qualifications; initiate and review vendor documentation before and after execution.This position operates in both the office and plant environments. Participate in capital projects as a design team member to ensure proper selection of new equipment in support of validation.Ensure adherence to DuPont???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.
Qualifications:Must have a Bachelor???s degree in Microbiology, Biology, Food Science, Process Engineering, or related field and a minimum of 5 years of experience in Validation. Must have experience adhering to cGMP???s, Food Safety GMP???s, and/or any other regulatory compliance procedures. 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.