Job Description
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 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
- Write clear, audit-ready technical documentation including protocols, reports, risk assessments, and standard operating procedures
- Support 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 processes
- Use SAP to support production orders, material/BOM data, and manufacturing records tied to molding operations
- Query and manipulate manufacturing/quality data using SQL to support process analysis, reporting, and validation data reviews
- Utilize RJG systems (e.g., eDART, CoPilot) and RJG-based validation methodology to monitor, control, and validate the injection molding process
- Support validation of HMI (Human-Machine Interface) systems and cloud/server-based platforms used in production and quality operations
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)
- Strong technical writing skills able to produce clear, structured, audit-ready protocols and reports
- Strong critical thinking and problem-solving ability; comfortable working through ambiguous or complex technical issues independently
- Proficiency 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 setting
- Working knowledge of SQL or other database tools for querying and analyzing manufacturing/quality data
- Knowledge of RJG process monitoring/control systems and RJG validation software (e.g., eDART, CoPilot) is required
- Experience validating HMI systems and cloud/server-based software platforms
Preferred:
- Experience in a medical device manufacturing environment (ISO 13485, FDA-regulated)
- Experience with automation/robotics validation on the production floor
- Six Sigma / Lean certification
Numbers & Facts
| Location | Houston, TX |
| Industry | Staffing/Employment Agencies |
| Company Size | 50 to 99 employees |
| Year Founded | 2015 |
| Website | http://www.honorvettech.com |
Benefits
401K, Employee Referral Program, Life Insurance
About Company
Is a leading Service Disabled Veteran Owned Small Business providing IT, Telecom and Medical Staffing.
Skills
- Analysis Skillsunmatched
- Automationunmatched
- Automation Systemsunmatched
- Bill of Materials (BOM)unmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Clinical Researchunmatched
- Cloud Computingunmatched
- Code of Federal Regulationsunmatched
- Computer Skillsunmatched
- Computer Systemsunmatched
- Consultingunmatched
- Continuous Improvementunmatched
- Contract Research Organization (CRO)unmatched
- Control Systemsunmatched
- Cross-Functionalunmatched
- Customer Satisfactionunmatched
- Data Qualityunmatched
- Document Controlunmatched
- Document Managementunmatched
- Equipment Validationunmatched
- FDA (Food and Drug Administration)unmatched
- FDA Requirementsunmatched
- Human Machine Interface (HMI)unmatched
- ISO (International Organization for Standardization)unmatched
- Identify Issuesunmatched
- Industrial Engineeringunmatched
- Injection Moldingunmatched
- Laboratory Information Management System (LIMS)unmatched
- Lean Six Sigmaunmatched
- Machine Toolunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Analysisunmatched
- Manufacturing Bill of Materials (mBOM)unmatched
- Manufacturing Operationsunmatched
- Medical Affairsunmatched
- Medical Equipmentunmatched
- Medical Office Administrationunmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Minitabunmatched
- Molding Processesunmatched
- Pharmacovigilanceunmatched
- Plastics Manufacturingunmatched
- Problem Solving Skillsunmatched
- Process Analysisunmatched
- Process Capabilityunmatched
- Process Engineeringunmatched
- Process Improvementunmatched
- Process Validationunmatched
- Product Lifecycle Managementunmatched
- Production Supportunmatched
- Production Systemsunmatched
- Programmable Logic Controller (PLC)unmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Quality Engineeringunmatched
- Query Analysisunmatched
- Regulationsunmatched
- Research Laboratoryunmatched
- Risk Analysisunmatched
- Roboticsunmatched
- Root Cause Analysisunmatched
- SAPunmatched
- SQL (Structured Query Language)unmatched
- SQL Databasesunmatched
- Six Sigma Certificationunmatched
- Software Validationunmatched
- Staff Requirementsunmatched
- Standard Operating Procedures (SOP)unmatched
- Statisticsunmatched
- System Validationunmatched
- Teamcenterunmatched
- Technical Writingunmatched
- Testingunmatched
- United States Department of Energy (DOE)unmatched
- Validation Documentationunmatched
- Validation Planunmatched
- Writing Skillsunmatched
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