Title:  Molding Process Engineer

Job Summary

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.

Essential Duties and 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

Education

•    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.

Work Experience

•    Minimum 3 years of experience in injection molding, process engineering, validation, or related regulated manufacturing environment required.

Preferred Knowledge, Skills and Abilities

•    Preferably has prior experience working in either the Medical, Packaging or Technological industries. 
•    Must have in-depth knowledge of Statistical Process Control (SPC) and Design of experiments (DOE).
•    Must have 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. 
•    Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
•    Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
•    Must be 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. 

Travel Requirements

Physical Requirements

Additional Requirements

•    Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality. 
•    Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues