Injection Molding Process Engineer I

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

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