Manufacturing Engineer

Our work truly matters and our resourcefulness can make all the difference in getting life-saving drugs to the people who need them when they need them. Were more efficient and effective when were not overly bound to a set way of working. Bring your resourcefulness and agility to continue your career at Sharp.

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 WRKIs Review MPRs 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:
Bachelors 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.