Validation Engineer

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• Designs, engineers, and implements quality systems to ensure regulatory compliance and quality improvements.
• Designs, plans, and executes validation activities for Over the Counter (O.T.C.) Drugs per FDA guidelines.
• Supports quality engineering initiatives (process capability studies, process improvement investigations) to improve quality, capacity, and efficiency while reducing costs.
• Plans, performs, and/or coordinates validation projects to ensure timely completion.
• Drafts and coordinates execution of validation documents for Equipment Qualification (IQOQPQ), Process Validation and Cleaning Validation/Verification.
• Provides technical guidance for SOPs/Work Instructions and other master documents and remains current with industry and regulatory trends.
• Provides technical leadership for deviation investigations, analyzing data and providing recommendations for process and equipment improvement.
• Prepares protocols and other technical documents, and participates in data interpretation, collaborating with other departments. Other responsibilities as directed.
• Interfaces with personnel in Quality Assurance Laboratories (Microbiology QCM, Chemistry QCA), Process Development, Product Integrity, Engineering, Contract Services, Regulatory Affairs, Package Engineering, Scheduling, Packaging, Processing and Central Weigh to design, plan, write protocols, execute, document results, and gain approvals for all validation activities (including product processing, packaging, utilities).
• Collaborates with Site/Corporate Engineering or Process Development and directs all Qualification activities for newly purchased equipment.
• Develops validation master plan, qualification, and validation schedule, ensuring projects and timelines align with FDA guidelines and informs QA management of status regularly.
• Plans and organizes all validation execution activities, including scheduling runs, collecting and analyzing data, documenting results, and coordinating resources.
• Compiles validation work in report format for future use, building a technology base of continuous quality improvement issues and solutions, and implements re-validation process improvements as required.
• Interfaces with QA, Packaging, Processing, etc., to identify potential areas for product quality and process improvement.
• Identifies sources of variation in manufacturing processes and seeks to reduce unnecessary variation using statistical and quality improvement tools (experimental design, statistical process control).
• Interacts with Engineering, Process Development, Commercialization, Quality, Stability.

• Experience:
  
  3+ years in food, drug or cosmetic consumer products manufacturing.
• Education:
  
  Bachelor/University Degree in Engineering, Science.
• Certifications:
  
  CQIA, quality engineer, 6 sigma would be a plus.
• Strong technical skills with Good Manufacturing Practices; certification by ASQ as CQE or CRE strongly preferred.
• Excellent written and oral communication skills and ability to facilitate communications between various groups.
• Detail-driven and results-oriented with ability to prioritize work in a fast-paced environment.
• Excellent interpersonal and leadership skills to lead teams to meet objectives.
• Excellent project management skills to coordinate multiple projects and meet tight timelines.
• Good presentation skills to provide training to various groups within the company.

Seniority level: Associate

Employment type: Contract

Job function: Pharmaceutical Manufacturing

Location: Lewisville, TX