Manufacturing Engineer at SHARP STERILE MANUFACTURING LLC

Allentown, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Mar, 26

Salary

0.0

Posted On

11 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Processes, Process Optimization, Troubleshooting, Equipment Management, Compliance, Documentation, Quality Control, Project Management, Training, Continuous Improvement, Lean Manufacturing, Six Sigma, Problem-Solving, Analytical Skills, Collaboration, Statistical Process Control

Industry

Pharmaceutical Manufacturing

Description

Summary: The Manufacturing Engineer will play a crucial role in the design, optimization, and troubleshooting of manufacturing processes to ensure efficient, safe, and high-quality production of pharmaceutical products. This position requires hands on trouble shooting of electromechanical packaging equipment. This position involves close collaboration with cross-functional teams to support process improvement, compliance with regulatory requirements, and continuous improvement in a highly regulated environment. Key Responsibilities: Process Optimization: Design, develop, and implement processes to improve manufacturing efficiency, reduce waste, and enhance product quality. Troubleshoot and resolve production issues to minimize downtime and ensure smooth operations. Equipment and Technology Management: Evaluate, select, and oversee the installation and maintenance of manufacturing equipment, ensuring they are functioning according to specifications and industry standards. Compliance and Documentation: Ensure all manufacturing activities comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards. Maintain accurate records, reports, and documentation in accordance with regulatory guidelines. Author technical documents such as Change Controls and WRKI’s, Review MPR’s etc. Quality Control and Assurance: Collaborate with quality assurance teams to identify and implement corrective actions, conduct root cause analysis for quality issues, and ensure continuous product quality in the production process. Project Management: Lead or participate in cross-functional teams for process improvement, facility upgrades, or new product introduction projects. Provide technical guidance on new product development and scale-up processes. Training and Support: Train and mentor operators and technicians on new processes, equipment, and safety procedures to ensure effective and efficient production workflows. Continuous Improvement: Identify opportunities for process automation, cost reduction, and other performance improvements. Foster a culture of continuous improvement using Lean, Six Sigma, or similar methodologies. Troubleshooting: Provide engineering support during production to resolve mechanical, electrical, or process-related problems in a timely manner. Safety and Risk Management: Promote a safe working environment by adhering to health and safety protocols and identifying any potential risks or hazards in the manufacturing processes. Required Qualifications: Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Pharmaceutical Engineering, or a related field. (Degree in progress will be considered) 3+ years of experience in a manufacturing engineering role, preferably within the pharmaceutical or life sciences industry. Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements (FDA, GMP, etc.). Experience with process design, process control, and equipment validation in a regulated manufacturing environment. Proficiency in the use of engineering software, such as AutoCAD, SolidWorks, or process simulation tools. Familiarity with Lean Manufacturing, Six Sigma, or similar continuous improvement methodologies. Excellent problem-solving, analytical, and troubleshooting skills. Strong communication and collaboration skills with the ability to work across cross-functional teams. Knowledge of statistical process control (SPC), root cause analysis, and design of experiments (DOE) is a plus. Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.

Responsibilities

The Manufacturing Engineer will design, optimize, and troubleshoot manufacturing processes for pharmaceutical products, ensuring efficiency and compliance. This role involves collaboration with cross-functional teams to support process improvements and maintain high-quality production standards.