Manufacturing Engineer II

Responsibilities

• Monitor and optimize manufacturing equipment performance in alignment with cGMP standards.
• Troubleshoot and resolve complex equipment issues to minimize production downtime.
• Lead lean manufacturing and Six Sigma initiatives to improve process efficiency and product quality.
• Identify and implement procedural or automation improvements for continuous optimization.
• Serve as a technical point of contact for clients and contract manufacturing services.
• Develop and maintain systems to visualize and analyze key performance indicators (KPIs).
• Support equipment-related deviations, CAPAs, and Change Controls as the equipment SME.
• Assist with Installation, Operational, and Performance Qualification (IOPQ) activities.
• Ensure equipment and processes meet regulatory requirements and are fit for commercial use.
• Oversee labeling, artwork changes, and packaging configurations as needed.

Qualifications

• Bachelor’s degree in Engineering or related field and/or equivalent experience
• 2+ years of relevant experience in manufacturing with a focus on equipment and process improvement.
• Proficiency in CAD software, primarily AutoCAD to design and update comprehensive factory and work cell layouts.
• Create, maintain, and update detailed technical documents, including assembly instructions, work instructions (WIs), and standard operating procedures (SOPs).
• Proven track record of successfully implementing improvement initiatives in a manufacturing environment.
• Strong analytical and problem-solving skills with the ability to use data to drive decision-making.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across multiple departments.
• Ability to manage multiple projects and priorities in a fast-paced environment.