Injection Molding Validation Engineer - CSV & Automation

Merck & Co.; Houston (TX); On-site; USD 69,000 - 124,000; Full time

Job summary

Merck & Co. in Houston seeks a contract Molding Process Engineer with expertise in software validation and automation to support medical device injection molding operations.

You will validate molding equipment and automation, apply statistics for process capability and work across Quality, Manufacturing, and Engineering to ensure compliance with FDA/ISO requirements and digital systems like Kneat and LIMS. On-site role requiring collaboration with cross-functional teams and hands-on validation

Qualifications

• Bachelor's in Mechanical/Manufacturing/Plastics/Industrial Eng or equivalent.
• Experience with injection molding in a regulated environment.
• Proven IQ/OQ/PQ and computer system validation experience.
• Familiar with Kneat or similar electronic validation platforms.
• Strong statistics skills (Minitab/JMP/Excel).
• Knowledge of 21 CFR Part 11 / Annex 11.
• Technical writing and audit-ready documentation ability.
• Independent problem-solving and critical thinking.

Responsibilities

• Develop/execute IQ/OQ/PQ validation for molding equipment and tooling.
• Lead/ support CSV and automation validation for molding systems (HMI/PLC/robotics).
• Manage validation docs in Kneat or similar system.
• Apply statistics to process capability studies and validation sizing.
• Ensure compliance with FDA ISO quality systems across teams.
• Investigate deviations and root cause analysis.
• Produce clear audit-ready protocols and reports.
• Validate MES/LIMS and electronic batch records integration.
• Collaborate with tooling, automation, and quality teams to optimize processes.
• Use SAP for production orders and BOM data; query data with SQL.
• Validate HMI and cloud/server-based platforms used in production.

Education

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

Tools

Kneat

TrackWise

MasterControl

Veeva

Minitab/JMP/Excel

SAP

SQL

RJG eDART/CoPilot

Teamcenter

Job description

Merck & Co. in Houston seeks a contract Molding Process Engineer with expertise in software validation and automation to support medical device injection molding operations.

You will validate molding equipment and automation, apply statistics for process capability and work across Quality, Manufacturing, and Engineering to ensure compliance with FDA/ISO requirements and digital systems like Kneat and LIMS. On-site role requiring collaboration with cross-functional teams and hands-on validation