Process Validation Engineer

Direct Contingent Worker

Direct Contingent Worker Posting Title: Direct Contingent Worker

Division: Country USA Work Location: Houston, TX

Functional Area: Technical Operations

Job Type: Full Time Employment Type: Contract

Job Description:

• Development of new injection molding processes using scientific molding principles.
• Lead complete IQ/OQ/PQ validation activities of both thermoplastic and silicone injection molds working with all stakeholders including Engineering, Production and Quality.
• Troubleshoot molding processes to mitigate production defects and or improve efficiency.
• Participate in design reviews of new tooling and equipment working with both external and internal injection mold makers.
• Lead technology improvements that advance our molding processes for new and existing products.
• Prepare complete and accurate records/documentation of assigned project activities per the established Quality System and Validation Guidelines.
• Participate in regular project meetings, publishes timely project updates, and follows-up continuously on all open critical path items.
• Generate and maintain documentation for applicable internal processes and procedures, inspection criteria, Bill of Materials, Validation Protocols/Reports and other manufacturing and quality records.
• Identify, initiate and implement technology improvements, which increase productivity and reduce scrap/reject rates through effective training of production personnel and process enhancements.
• Maintain and improve product quality by performing and documenting robust root cause investigations and implementing effective corrective and preventive actions.
• Develop and leverage product knowledge to ensure Critical Quality Attributes (CQAs) are consistently met.

Minimum Education Requirements:

• Bachelor degree in Engineering or equivalent years of directly related experience (or high school +8yrs; Assoc. +4 yrs; Scientific Molding Certifications (master molder) +2yrs)

Direct Contingent Worker:

• Preferred: Bachelor degree in Plastics Engineering or Scientific Molding Certification completion.

Minimum Experience Requirements:

• Minimum: 2 years experience in high volume molding and manufacturing environment
• Preferred: 2 years experience in medical device manufacturing or other highly regulated industry
• Working knowledge of Validation processes (IQ/OQ/PQ)
• Technical expertise in injection molding of thermoplastics related to Design for Manufacturability of molds, processing of thermoplastics, robotics, automation and hot runner system
• Comprehensive knowledge and thorough understanding of troubleshooting techniques for the injection molding process, machine, robot and auxiliaries.
• Experience with advanced processing techniques (eDart), robot programming, hot runner molds, tooling issue diagnostics, molding machine diagnostics, central material handling systems and color blending.
• Processing knowledge of Polycarbonate, Acrylic, ABS, Polysulfone, and various commodity resins
• Familiar with SPC methodologies and the scientific molding process.
• Data driven, disciplined, objective and detail oriented.
• Ability to read and interpret part and mold drawings
• Ability to work with minimal supervision and/or guidance
• Familiarity with statistical problem solving techniques
• Excellent organization and communication skills.
• Knowledge of FDA regulations and other international compliance standards
• Competency in the following software: MS Project, Excel, Word, PowerPoint

EEO Statement: Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.