Pharmaceutical Validation Engineer

2 months ago

Bedford Park, United States Ingredion Full time

Pharmaceutical Validation Engineer Location: Argo Plant. Bedford Park, IL.
Reports to: Quality Assurance Manager
Workplace type: On-Site As a
Pharmaceutical Validation Engineer ,
you will be part of a great team of Quality Assurance Team and you will be responsible for the 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 ensure successful integration and completion of validation activities in overall project schedules.Your role will be: Responsible for the development, execution & analysis of validation projects to demonstrate facility cGMP compliance.Responsible for 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/CAPA's, 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), prequalification, and revalidation of critical systems and utilities.Your profile needs these qualifications: 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 FDA/cGMP compliant environment required.Strong collaboration, communication, and presentation skills are required.You'll need these skills to be successful: Expertise with the following: Bulk Fillers, Continuous Manufacturing, GAMP, API, ExcipientsExperience 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.Ingredion Total Rewards and Benefits
We offer a competitive and comprehensive package that aligns with our values and goals. It includes salary, incentives, health, retirement, flexibility, learning, recognition, and wellness. Relocation Available: Yes, Within CountryWe are an equal opportunity employer and value diversity at our company. Ingredion seeks to provide a work environment that is free from harassment and discrimination. We will not tolerate any form of discrimination based on race, color, religion, age, gender, gender identity, gender expression, national origin, ancestry, handicap or disability-mental or physical-marital status, sexual orientation, veteran status, disability resulting from military service, or any other classification protected by law ("protected classifications"). We are committed to establishing and maintaining a work environment where everyone is treated with dignity and respect. Ingredion provides accommodations to job applicants with disabilities throughout the hiring process. If a job applicant requires an accommodation during the application process or through the selection process, we will work with the applicant to meet the job applicant's accommodation needs.

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