Molding Process Engineer

West Pharmaceutical Services • Scottsdale, AZ

2d • Onsite

About The Position

This onsite Molding Process Engineer will provide technical direction for high-precision injection molding processes in a regulated pharmaceutical manufacturing environment. This role is responsible for process development, validation, troubleshooting, continuous improvement, and lifecycle process control for molded components. The Molding Process Engineer will partner with Manufacturing, Quality, Maintenance, Tooling, Automation, Validation, and Regulatory teams to ensure robust, capable, compliant, and cost-effective manufacturing processes.

Requirements

• Bachelor’s Degree in Plastics Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline required or relevent experience may be considered in lieu of degree.
• Minimum 3 years of experience in injection molding, process engineering, validation, or related regulated manufacturing environment required.

Nice To Haves

• Prior experience working in either the Medical, Packaging or Technological industries.
• In-depth knowledge of Statistical Process Control (SPC) and Design of experiments (DOE).
• Working knowledge of all the molding processes in the plant and the associated tooling for each; including tooling design and manufacture. Demonstrative knowledge of variability, numerical reasoning and computer applications.
• Experience with manufacturing data systems, MES, ERP, SPC software, electronic documentation systems, data visualization tools, and validated computerized systems.
• Excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Able to organize and prioritize tasks; must be detail orientated and self-motivated.
• Able to deal with all levels of employees and work across various departments.
• Experience in writing and executing validation protocols and reports.
• Collaborates effectively as part of a team to support department and organizational goals.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

Responsibilities

• Leads or supports equipment, mold, automation, and process qualifications, including URS, FAT, SAT, IQ, OQ, and PQ as applicable.
• Writes technical reports, protocols, change controls, issue reviews as required to defend or support decisions concerning material acceptability.
• Provides process support to the production facilities as required. Requires working knowledge of all injection molding processing equipment (i.e. materials, molding, tooling, etc.)
• Develops and documents validated process windows using scientific molding principles.
• Supports investigations for nonconformances, deviations, customer complaints, and audit observations.
• Collaborates with Tooling and Maintenance teams on mold design reviews, mold qualifications, preventive maintenance, spare-part strategy, and tool performance monitoring.
• Uses manufacturing data systems to monitor process performance, downtime, scrap, yield, and process capability.
• Works within timelines to ensure timely completion of assigned projects.
• Ensures quality of all materials used in the process by developing and implementing effective reliable testing techniques.
• Ensures continued reliability of testing techniques by maintaining current knowledge of all technical and analytical information.
• Establishes and implements reliable procedures to ensure compliance with good manufacturing practices.
• Provides project leadership for materials- and process-related projects by coordinating the efforts of the various departmental disciplines for successful completion according to plan and budget.
• Supports the efforts of production in related areas as a technical advisor.
• Reviews and analyze process data using tools such as Minitab, JMP, Power BI, Excel, or equivalent.
• Takes appropriate action to ensure compliance with all safety, health and hazardous communication standards.
• Ensures that established policies, rules and regulations, and procedures are followed.
• Other duties as assigned

Benefits

• Benefit programs that empower the physical, mental, emotional and financial health of our team members and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level