Manufacturing Sr Engineer I

About the role

The Senior Manufacturing Engineer I at Zimmer Biomet supports efficient manufacturing processes through various engineering services including cell management, process development, project management, process validation, root cause investigation, and troubleshooting.

Responsibilities

• Create, maintain, and improve controlled technical documents such as prints, procedures, qualification and validation protocols and reports.
• Support a wide variety of processing applications including 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.
• Execute 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.
• Develop and execute 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 from other departments.
• Brainstorm ideas for cost savings and lean manufacturing. Balance opportunities and prioritize.

Requirements

• 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.
• 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.

Qualifications

• 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.

Skills

• GMP manufacturing and regulations.
• ISO 13485.
• Drafting and use of AutoDesk/ Solidworks.
• Project management and leadership.
• Problem-solving and quality improvement techniques.
• Communication skills (written and verbal).
• Control procedures (Change Management System, Nonconformance Reports, etc.).
• Statistical Process Control concepts.
• Microsoft Office Suite and Project proficiency.

Benefits

• Flexible working environment.
• Location-specific competitive total rewards.
• Wellness incentives.
• Culture of recognition and performance awards.
• Employee resource groups (ERGs).
• Recognition and value for team members.
• Strong sense of belonging.

Pay

Details about pay are not specified in this job posting.

Schedule

Details about schedule are not specified in this job posting.