Pharmaceutical Validation Engineer

Pharmaceutical Validation Engineer

Join Ingredion Incorporated. Join Ingredion where innovation impacts lives worldwide! Without even realizing it, you’ve experienced our work in your favorite chocolate, your pet’s food, the paper you write on, and your everyday snacks. As a global powerhouse across more than 60 industries, we harness the potential of natural ingredients to transform lives. Whether you’re just starting your career or bringing years of experience, there's a place for you here to make a real difference.

Be part of our team that values a wide range of perspectives and is committed to shaping a better world with every product we create.

Location: Argo Plant – Bedford Park, IL.

Workplace type: On Site

As a Pharmaceutical Validation Engineer, you will be responsible for development, execution, & analysis of validation projects to demonstrate facility, equipment, and process consistency and cGMP compliance for an API facility. Responsibilities include the generation and execution of IQ/OQ/PQ protocols and summary reports. The Validation Engineer will also collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches.

Other duties include providing validation project management for validation activities at the site, in addition to projects such as new or modified facilities; acting as an interface between various functional areas (internal and external) to assure successful integration and completion of validation activities in overall project schedules.

• Responsible for the site Master Validation Plan.
• Responsible for API and Excipient Change Control Program authoring change controls, SOPs, and work instructions.
• Review, plan, schedule, and organize validation projects for new and existing areas, including manufacturing equipment, processes, plant systems, storage facilities, and equipment.
• Provide technical assistance to change controls/CAPAs, and deviations.
• Design and execute process and cleaning validation studies meeting site and industry standards.
• Assist with troubleshooting investigations and continuous improvement initiatives.
• Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches.
• Perform risk assessments and impact analyses to identify potential issues and develop mitigation plans.
• Ensure compliance with data integrity requirements and implement measures to maintain data integrity throughout the validation lifecycle.
• Support and provide guidance to the project team regarding CSV (Computer Systems Validation) principles and best practices.
• Participates in regulatory audits by government regulatory agencies and audits by customers.
• Help develop and maintain drawings and diagrams for regulatory agencies and in plant use.
• Maintain all necessary standard operating procedures for validation of plant processes, equipment installation, and operational qualification (IQ/OQ), performance qualification (PQ), requalification, and revalidation of critical systems and utilities.

• Expertise with the following:
  Bulk Fillers, Continuous Manufacturing, GAMP, API, Excipients
• Experience working in the pharmaceutical industry.
• Demonstrated application of engineering, validation, and regulatory concepts, technical principles, and judgment to address a broad range of difficult projects/problems.
• Ability to perform effectively in high‑stress situations. Demonstrated ability to train and coach to timelines to improve performance.
• Capacity to solve problems through creative, innovative solutions and challenge traditional methods of accomplishing tasks.
• Ability to build consensus and foster positive relationships.
• Ability to learn and apply Ingredion’s Safety, GMP, Quality, and Continuous Improvement standards.

• A Bachelor of Science degree in Pharmacy, Engineering, or Science is required.
• 3+ years of experience in life sciences engineering is required.
• 3+ years of experience in validation is required.
• Experience working in an FDA/cGMP compliant environment required.
• S…