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Pharmaceutical Validation Engineer
Pharmaceutical Validation EngineerIngredion • Cook County, Illinois, USA
Pharmaceutical Validation Engineer

Pharmaceutical Validation Engineer

Ingredion • Cook County, Illinois, USA
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  • [job_card.full_time]
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Pharmaceutical Validation Engineer

About Ingredion :

Join Ingredion where innovation impacts lives worldwide! Without even realizing it youve experienced our work in your favorite chocolate your pets 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 youre just starting your career or bringing years of experience theres 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 Bedoford 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 interface between various functional areas (internal and external) to assure successful integration and completion of validation activities in overall project schedules.

What you will do :

  • 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.

What you will bring :

  • 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 Ingredions Safety GMP Quality and Continuous Improvement standards.
  • Who you are :

  • 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.
  • Strong collaboration communication and presentation skills required.
  • Why Join Ingredion

    Discover why Ingredion is the ideal place to advance your career with our exceptional rewards and benefits package designed to help you thrive. Create the future with us and enjoy :

  • Total Rewards Package Competitive salary and performance-based pay recognizing your contributions to our success
  • Comprehensive Benefits & Wellness Support Health long-term savings and resources for your physical mental and emotional well-being
  • Career Growth Learning training and development opportunities including tuition reimbursement
  • Employee Recognition Program A culture of real-time appreciation with personalized recognition rewards globally
  • Employee Discount Program Provides exclusive discounts on everyday products services and travel
  • #LI-DR1 #LI-ONSITE

    Relocation Available :

    No

    Pay Range :

    $81680.00-$108906.67 Annual

    This pay range is not a guarantee of compensation or salary. Final base salary will be determined based on several factors which may include but are not limited to responsibilities of the job education experience knowledge skills and abilities as well as internal equity alignment with market data and applicable bargaining agreement (if any).

    Incentive Compensation :

    As a part of the total compensation package this role may be eligible for the Ingredion Annual Incentive Plan or a role-specific commission / bonus.

    Benefits :

    Full-time roles are eligible for our comprehensive benefits package which includes medical dental and vision coverage as well as a 401(k) plan with an competitive company match.

    We 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 disabilitymental or physicalmarital 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 applicants accommodation needs.

    Ingredion uses AI-enabled tools to support parts of the recruitment process including resume screening and interview scheduling. These tools help match candidate skills to job requirements and streamline communication. All AI-assisted decisions are reviewed by our Talent Acquisition team to ensure fairness and compliance with applicable laws. By applying you acknowledge that AI may be used to support your application journey.

    Relocation Available :

    No

    Pay Range :

    This pay range is not a guarantee of compensation or salary. Final base salary will be determined based on several factors which may include but are not limited to responsibilities of the job education experience knowledge skills and abilities as well as internal equity alignment with market data and applicable bargaining agreement (if any).

    Incentive Compensation :

    As a part of the total compensation package this role may be eligible for the Ingredion Annual Incentive Plan or a role-specific commission / bonus.

    Benefits :

    Full-time roles are eligible for our comprehensive benefits package which includes medical dental and vision coverage as well as a 401(k) plan with an competitive company match.

    Key Skills

    Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

    Yearly Salary Salary : 81680 - 108906

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