Injection Molding Validation Engineer

HonorVet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations. Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction. Job Title : Injection Molding Process Engineer I Location: Houston , TX (Onsite) Duration: 24 months Job Description : 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. This role goes beyond traditional process engineering the ideal candidate combines deep injection molding process knowledge with computer systems validation (CSV) expertise, statistical analysis skills, and hands-on experience with computerized quality systems such as Kneat. This person will play a key role in validating molding equipment, automation, and the digital systems that support our quality and manufacturing operations. Key Responsibilities:Develop, execute, and document process validation protocols (IQ/OQ/PQ) for injection molding equipment and toolingLead 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 effortsPartner 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 analysisWrite clear, audit-ready technical documentation including protocols, reports, risk assessments, and standard operating proceduresSupport integration and validation of computerized systems used in production and quality operations (e.g., MES, LIMS, electronic batch records, Teamcenter or similar PLM tools)Collaborate cross-functionally with tooling, automation, and quality engineering teams to troubleshoot and optimize molding processesUse SAP to support production orders, material/BOM data, and manufacturing records tied to molding operationsQuery and manipulate manufacturing/quality data using SQL to support process analysis, reporting, and validation data reviewsUtilize RJG systems (e.g., eDART, CoPilot) and RJG-based validation methodology to monitor, control, and validate the injection molding processSupport validation of HMI (Human-Machine Interface) systems and cloud/server-based platforms used in production and quality operationsRequired 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 environmentProven experience with process validation (IQ/OQ/PQ) and computer system / automation validationWorking 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)Strong technical writing skills able to produce clear, structured, audit-ready protocols and reportsStrong critical thinking and problem-solving ability; comfortable working through ambiguous or complex technical issues independentlyProficiency with standard computer tools (MS Office/Excel; PLM/document control systems such as Teamcenter is a plus)Working knowledge of SAP (production orders, BOMs, material master data) in a manufacturing settingWorking knowledge of SQL or other database tools for querying and analyzing manufacturing/quality dataKnowledge of RJG process monitoring/control systems and RJG validation software (e.g., eDART, CoPilot) is requiredExperience validating HMI systems and cloud/server-based software platformsPreferred:Experience in a medical device manufacturing environment (ISO 13485, FDA-regulated)Experience with automation/robotics validation on the production floorSix Sigma / Lean certification