Validation Engineer

• Lead high‑impact validation work with strong growth and top‑tier compensation.
• Shape critical pharma systems in a modern, career‑advancing environment.
  
  

About Our Client

A leading U.S. manufacturer of healthcare and personal‑care products, known for decades of expertise in formulation, filling, and packaging. The company supports major medical, pharmaceutical, and consumer brands with high‑quality, FDA‑regulated production, fast turnaround, and a strong commitment to safety, reliability, and innovation.

Job Description

Essential Functions:

• Develop and maintain validation master plans, process flow diagrams, test cases, and Standard Operating Procedures (SOPs).
• Develop and improve validation programs as needed to remain current with cGMPs and industry standards.
• Represent Quality in teams assembled to specify, procure, install, qualify, validate, troubleshoot, and maintain production systems, equipment, and processes.
• Develop and maintain calibration schedules for all necessary equipment in product manufacturing.
• Direct validation activities, such as protocol creation, scheduling, testing, assessment, reporting, and archiving.
• Design validation study features such as sampling, testing, or analytical methodologies.
• Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, utilities, equipment, cleaning processes, computer, and new products for pharmaceutical production.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols and external standards.
• Program and operate department analytical instruments (such as temperature/humidity data loggers) to perform controlled temperature/humidity qualifications (e.g., warehouses, sterilizers, incubators, etc.).
• Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.
• Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
• Conduct audits of validation or performance qualification processes to ensure compliance with internal and regulatory requirements.
• Conduct and/or participate in deviation investigations to identify root causes and define corrective and/or preventive actions (CAPA).
• Create, populate, and maintain databases for tracking validation activities and qualified/validated systems.
• Identify deviations from established product or process standards and provide recommendations for resolving deviations through technical change control and/or requalification.
• Resolve testing problems by modifying testing methods or revising test objectives and standards.
• Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
• Assist in training equipment operators and other staff on validation protocols and standard operating procedures.
• Maintain validation test equipment and manage the company calibration program, activities, scheduling, and documentation.
• Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
• Other duties as assigned.
  
  

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Education, Abilities And Skills

• Minimum 4-year degree in a Science or Engineering field of study; or equivalent experience.
• Generation of protocols, reports, deviations, and other technical documents.
• PC literate with standard MS-Office application (Word, Excel, PowerPoint, Project, Access) competency.
• Understanding of statistical analysis tools and methods. ASQ-CQE certification preferred.
• Knowledge and understanding of cGMPs and industry guidance. Preferred 3-5 years of related experience in a cGMP facility. Pharmaceutical manufacturing experience preferred.
• Knowledge of calibration metrology processes.
• Knowledge of cGMP Equipment Qualification requirements and techniques.
• Knowledge of cGMP Cleaning Validation requirements and techniques.
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• Knowledge and experience in CAPA, root-cause analysis, risk assessment, investigation tools and techniques.
  
  

Experience

• Pharmaceutical Industry: 3 years (Required)
• Validation: 4 years (Required)
  
  

Physical Requirements

• Ability to lift up to 25 pounds
• Ability to stand, walk, climb, bend, and stoop throughout the shift
• Use of hands 100% of the workday
  
  

What's on Offer

• Hourly pay between $45 and $52/hr , based on experience.
• Access to medical, dental, and vision benefits.
• Opportunities to work within a collaborative and professional environment.
• Contract to Hire opportunity - Salaried upon conversion
• Upon conversion: 401(k), 401(k) matching, Dental insurance, Health insurance, Life insurance, Paid time off, Vision insurance
• Chance to contribute to impactful projects in the fast-paced Manufacturing industry.
  
  

If you're ready to bring your expertise as a Validation Engineer to a rewarding role in Elgin, we encourage you to apply today!

Contact: Jackson Edwards

Quote job ref: JN-032026-6982841