Manufacturing Engineer

This manufacturing engineer role supports all aspects of product transfer, including production line setup at a specified facility. The engineer collaborates within a cross-functional and global team to implement new manufacturing equipment and processes. They develop creative solutions to manufacturing challenges, incorporating new technologies and innovative techniques. Responsibilities include ownership of equipment sourcing, validation and implementation within the quality system, with opportunities to mentor junior staff. The role involves process ownership, driving process and equipment improvements, and managing strategic and cost projects. The engineer also interfaces with Quality and Research and Development to integrate new products or processes and address quality issues.

Key Responsibilities:

• Support the transfer of products to the designated facility.

• Develop in-depth knowledge of manufacturing processes, including production and process controls.

• Develop and perform equipment/software qualifications, process characterizations, process validations and test method validations.

• Initiate and complete technical activities for new or improved products or processes, for current and future programs, and to meet strategic goals.

• Act as a process owner, driving engineering activities with an emphasis on equipment/systems validation lifecycle according to procedures and standards.
• Demonstrate broad knowledge of manufacturing process technologies and quickly develop expertise.

• Evaluate and lead the implementation of new equipment/processes through research, analysis, and selection of software designs and operating systems, using engineering best practices.

• Provide expert problem-solving with a strong understanding of engineering principles.

• Coordinate and conduct technical investigations and documentation of non-conforming events and trends, developing investigation plans.

• Continuously improve processes and work methodologies through collaboration and analysis of workflows.

• Incorporate business policies and procedures, demonstrating an understanding of business and customer needs.

• Understand the business cycle and emerging technology trends.

• Contribute to a strong team culture focused on high expectations and performance.

• Provide clear communication to stakeholders.

Education & Experience:

• Bachelor's Degree in Engineering/Science is essential.

• 3+ years of experience in a manufacturing environment is required.

• Experience with relevant regulatory bodies is desirable.

• Experience in validation lifecycle is required.

• The successful candidate must be a self-starter with strong teamwork skills and the ability to work on their own initiative.

• Availability for short-term travel is desirable.