Process Engineer I-2nd Shift

Unclassified

Full-time - Entry Level

About the position

At PCI, we are committed to making a global impact through life-changing therapies. We are currently seeking a dedicated Process Engineer to provide technical leadership for new product launches and lead continuous improvement activities. This role is crucial in identifying and mitigating packaging issues for existing business operations through strong engineering and process improvement methods. The Process Engineer will focus on delivering technical and operational support to production, maintenance, and support staff, which includes process improvement, equipment modification, optimization, safety, quality improvement, and increasing throughput. The successful candidate will utilize their strong understanding of good engineering practices and lean six sigma techniques to achieve these goals. This position requires excellent organizational and leadership skills to determine staffing projections, equipment needs, equipment purchases, installations, component layouts, and line layouts. The role operates on a 2nd shift schedule, from 3 PM to 11 PM, Monday to Friday, and may require overtime and/or weekend work as necessary. Essential duties include analyzing sales requests to determine necessary equipment and tooling, performing engineering reviews of components for new jobs, and applying sound engineering principles to design new production lines. The Process Engineer will also participate in customer meetings, interact with sales departments to determine requirements for new products, and prepare standard operating procedures (SOPs) and production line diagrams as needed. Additionally, the role involves specifying, ordering, and commissioning tooling for launch activities, writing capital equipment requests, and leading validation protocols and commissioning of equipment. The Process Engineer will also facilitate cross-functional Lean Six Sigma process improvement teams and measure performance metrics to spearhead initiatives aimed at decreasing variability and waste.

Responsibilities

• Analyze sales requests to determine equipment, tooling, or delivery systems needed.
• Perform engineering review of all components for new jobs, including size and capability of equipment.
• Apply sound engineering principles to design new production lines and component layouts.
• Conduct and participate in customer meetings and attend occasional off-site meetings.
• Interact with the sales department and customers to determine requirements for new products and orders.
• Prepare SOPs, line layouts, and production line diagrams as needed.
• Specify, order, and commission tooling for launch activities.
• Write Capital Equipment Requests (CERs) for new equipment and negotiate orders when approved.
• Write protocols for User Requirement Specifications (URS), Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT).
• Determine Operational Qualification (OQ) parameters to start validation and approve validation protocols.
• Commission equipment including necessary change controls and training, leading FAT and SAT activities.
• Research new trends and technologies in packaging and evaluate new equipment and processes.
• Assist Validation with OQ and Performance Qualification (PQ) of new packaging business.
• Lead CAPA investigations and troubleshoot packaging problems.
• Facilitate cross-functional Lean Six Sigma process improvement teams using DMAIC method.
• Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste.

Requirements

• Bachelor's Degree in mechanical, packaging engineering, or a related field of study.
• 1-5 years of related experience and/or training.
• Intermediate computer skills with the ability to perform complex tasks and knowledge of various computer programs.
• Full professional proficiency in speaking, reading, and writing relevant to professional needs.
• Very high reasoning ability to define problems, collect data, establish facts, and draw valid conclusions.

Nice-to-haves

• Excellent time management skills.
• Ability to effectively present information to various stakeholders.
• Original thinking and creativity in problem-solving.
• Ability to set and achieve challenging goals.