Citralabs

The Senior Manufacturing Engineer I is responsible for providing manufacturing engineering services to support efficient manufacturing processes. Engineering services may include cell management, process development, project management, process validation, root cause investigation and troubleshooting.

• Creating, maintaining, and improving controlled technical documents such as prints, procedures, qualification and validation protocols and reports.
• Supporting a wide variety of processing applications such as drug product formulation and filling, steam sterilization, visual inspection, automated labelling, compound mixing, centrifuge, drying oven, dispensing and sterile barrier packaging.
• Execute validation maintenance activities for drug product manufacturing. Executing validation studies for equipment performance requirements.
• Initiate and manage change controls for changes affecting product and process performance and quality. Lead investigation and root cause analysis for manufacturing issues, and establish a robust resolution.
• Developing and executing project plans and schedules for medium to large projects. Report to management team on progress, risk and risk mitigation, and recovery plans as needed.
• Communicate (written and verbal) direction and project plans with appropriate personnel form other departments.
• Brainstorm ideas for cost savings and lean manufacturing. Balance opportunities and prioritize.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

• Skilled and knowledgeable in GMP manufacturing and regulations. In depth knowledge of ISO 13485.
• Knowledge with drafting and use of AutoDesk/ Solidworks.
• Ability to lead and prioritize multiple medium complexity project assignments and complete work in a timely manner.
• Good problem-solving skills through the use of quality and statistical tools.
• Demonstrates good written and verbal communication skills.
• Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions.
• Proficient with Statistical Process Control concepts, process development, Microsoft Office Suite and Project.

• B.S. in Engineering with a minimum of 3-5 years of manufacturing engineering experience.
• Knowledge in Lean Principles and or Six Sigma or other problem-solving methodology is preferred.

• Up to 10%

$80,727 - $100,909