Injection Molding Process Engineer with CSV & Automation

Mindlance; Houston (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Mindlance seeks a contract Injection Molding Process Engineer in Houston, onsite, for a 24‑month assignment. The role combines deep molding expertise with CSV, statistics and validated digital systems to support FDA/ISO compliance.

You will validate molding equipment, automation and data systems, lead validation activities, and work cross‑functionally to drive quality improvements in a regulated manufacturing environment.

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Plastics/Industrial Engineering or equivalent hands‑on experience.
• Solid experience with injection molding processes (LSR/thermoplastic) in regulated environments.
• Proven process validation (IQ/OQ/PQ) and computer system/automation validation.
• Familiarity with Kneat or similar electronic validation platforms (TrackWise, MasterControl, Veeva).
• Strong statistical analysis skills (Minitab/JMP/Excel).
• Knowledge of 21 CFR Part 11/Annex 11 and data integrity principles.
• Strong technical writing and audit-ready documentation skills.

Responsibilities

• Develop, execute, and document IQ/OQ/PQ validation protocols for molding equipment and tooling.
• Lead or support CSV and automation/equipment validation for molding systems (HMI, PLC, robotics, vision, data acquisition).
• Author and manage validation documents in Kneat or equivalent systems.
• Apply statistics (Cpk/Ppk/DOE/SPC/MSA) for process capability studies and validation sizing.
• Collaborate with Quality, Manufacturing and Engineering to ensure regulatory compliance.
• Investigate deviations and perform root cause analysis; document conclusions clearly.
• Support MES, LIMS and electronic batch records validation in production and quality ops.
• Use SAP to support production orders and BOM data; query data with SQL.

Skills

Process validation

Statistical analysis

Technical writing

SQL querying

Problem solving

Cross-functional collaboration

ISO quality awareness

Education

Bachelor's degree in Mechanical/Manufacturing/Plastics/Industrial Engineering

Equivalent hands-on experience

Tools

Kneat

TrackWise/MasterControl/Veeva

SAP

RJG eDART/CoPilot

Teamcenter

SQL/database tools

Job description

Mindlance seeks a contract Injection Molding Process Engineer in Houston, onsite, for a 24‑month assignment. The role combines deep molding expertise with CSV, statistics and validated digital systems to support FDA/ISO compliance.

You will validate molding equipment, automation and data systems, lead validation activities, and work cross‑functionally to drive quality improvements in a regulated manufacturing environment.