Validation Engineer - Injection Molding

Title : Injection Molding Process Engineer I

Location : Houston TX

Duration : 12 Months

We are seeking a contract Molding Process Engineer with a strong specialization in software and automation validation to support our medical device injection molding operations.

Key Responsibilities

• Develop, execute, and document process validation protocols (IQ/OQ/PQ) for injection molding equipment and tooling
• Lead or support computer system validation (CSV) and automation/equipment validation activities for molding-related systems (HMI, PLC-controlled equipment, robotics, vision systems, data acquisition systems)
• Author, review, and manage validation documentation within Kneat (or equivalent electronic validation lifecycle management system)
• Apply statistical methods (e.g., Cpk/Ppk, DOE, SPC, MSA, hypothesis testing) to support process capability studies, validation sample sizing, and continuous improvement efforts
• Partner with Quality, Manufacturing, and Engineering teams to ensure compliance with applicable quality system regulations (FDA 21 CFR Part 820, ISO 13485, Part 11 / Annex 11 for computerized systems)
• Investigate process deviations, non-conformances, and equipment issues, applying structured critical thinking and root cause analysis

Required Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Plastics, Industrial Engineering, or related technical field (or equivalent hands-on experience)
• Solid, demonstrable experience with injection molding processes (LSR and/or thermoplastic) in a regulated manufacturing environment
• Proven experience with process validation (IQ/OQ/PQ) and computer system / automation validation
• Working knowledge of an electronic validation platform such as Kneat (or similar: TrackWise, MasterControl, Veeva)
• Strong statistical analysis skills (Minitab, JMP, or Excel-based statistical tools)
• Familiarity with computerized quality systems and data integrity principles (21 CFR Part 11 / Annex 11)