Senior Manufacturing Engineering II

Responsibilities

• Lead efforts to monitor and optimize the performance of manufacturing equipment ensuring compliance with CGMP standards.
• Troubleshoot and resolve complex issues to minimize production downtime.
• Identify and implement opportunities for continuous improvement through upgrades, process modification, or alternative solutions.
• Lead in the development and implementation of procedural or automation improvement changes.
• Lead lean manufacturing initiatives, six sigma projects, and other process optimization efforts to improve productivity, quality, and cost efficiency.
• Assist with new product / equipment design reviews, process development and commercialization activities including training and development of manufacturing staff on operation and process.
• Serve as a technical point of contact for client and contract services.

Data Analytics and Performance Analysis

• Develop and maintain measurement systems to visualize manufacturing key performance indicators (KPIs).
• Use data analytics tools and techniques to analyze equipment performance, identify trends, and recommend corrective action and process improvement.

Quality System / Equipment Qualification Support

• Assist with manufacturing equipment-related deviations and root cause analysis as the equipment SME.
• Support the development and execution of Corrective and Preventive Actions (CAPA) and Change Controls to address root causes of equipment failures and performance issues.
• Support equipment Installation, Operation, and Performance Qualification (IOPQ) activities.
• Provide SME input on equipment qualification processes, ensuring fit for commercial manufacturing use, compliance with FDA and other regulatory requirements.

Qualifications

• Basic Qualifications: Bachelor’s degree in Engineering or related field and/or equivalent experience, 8+ years of manufacturing experience in the pharmaceutical industry with a Bachelor’s degree; and 6+ years’ experience in the pharmaceutical industry and a Master’s degree or a PhD with 3 years in the pharmaceutical industry and a focus on equipment and process improvement.
• Proven track record of successfully implementing improvement initiatives in a pharmaceutical 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, Technical writing experience such as: SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal, Experience with automation, nasal, or related drug delivery device manufacture and packaging.
• Preferred Qualifications: Lean manufacturing or Six Sigma certifications, Proficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc., Experience with site-level automation systems, ex. Serialization - Antares, Tracelink, Data historian – Aveva OSI PI, Reporting Systems – OSI PI, MS Report Builder, SQL Development, Kepware, Matrikon, AB Factory Talk, Automated Visual Inspection, Other duties as assigned.

Physical Requirements

• Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus to read/understand/execute documentation as required by the position.
• Employees are required to follow all cGMP and safety procedures.
• The employee must wear all required safety equipment and safely perform assigned work.
• The employee must occasionally lift and/or move up to 20 pounds.