QA Pharma Compliance Process Engineer – Nutrition and Health
To design, plan, and support in the validation of equipment and processes 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.
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 responsible for validation support at the Madison site. ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential functions of this position include, but are not limited to, the following:
Troubleshoot equipment and process issues in assurance of successful validation. Provide support for technical design or process changes to improve efficiency, quality or performance to ensure successful validation.Prepare and plan validation studies in support of ongoing validation. Coordinate validation study testing with affected departments and personnel.Perform system and component level impact assessments for manufacturing equipment. Verify drawings, P&IDs, flow diagrams, etc. as needed in support of validation.Provide support in the review and execution of qualification and validation protocols on manufacturing equipment and processes as well as for new or modified manufacturing processes, systems or equipment for pharmaceutical production.Perform change assessments in regards to impact on qualified manufacturing equipment and validated processes. Identify deviations from established processes and provide recommendations for resolution.Participate in capital projects as a design team member to ensure proper selection of new equipment in support of validation. Provide support for review of commissioning for new manufacturing equipment. This position operates in both the office and plant environments. Qualifications:Must have a Bachelor???s degree in Engineering (or related field) with a minimum of 5 years of engineering experience OR have a Bachelor???s degree in Microbiology, Biology, Food Science, or related field with a minimum of 10 years of experience in manufacturing specifically involving fermentation and/or freeze drying processes and equipment.Experience in process engineering in regards to cultures and/or a good working knowledge in principles of fermentation and freeze drying is preferred but not required.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.Experience with reading and verifying P&IDs, process flow diagrams, system drawings, etc.Must possess strong organizational and time-management skills and the ability to work independently.Must possess effective communication, interpersonal, team-building skills at various levels with other departments.Experience in Validation, Quality Assurance, Quality Control role utilizing cGMP???s, Food Safety, and/or Regulatory Compliance preferred but not required. Experience with regulatory compliance of products with respect to dietary supplements, food, bulk pharmaceuticals is preferred but not required.