Job Summary

Provides engineering support to Packaging to trouble shoot and resolve complex problems involved with day-to-day production operations. Monitor the day-to-day performance of the packaging departments. Develop, propose, implement and/or follow up on packaging equipment, packaging automation improvements involved in ongoing operations (e.g., variable cost, productivity, quality, reliability, and maintenance).

Job Details

This position is responsible for the following:

• Timely resolve of production problems and issues as they arise.
• Leading packaging equipment and packaging equipment automation improvement projects which deliver Cost, OEE and / or Compliance improvements
• Driving engineering and production processes improvement utilizing Lean and MEP (Maintenance Excellence Program) principles.
• Providing on-the-job training to new mechanics on the technical aspects of the production.
• Mastery of technical production related competencies (e.g., understand production information, build/assembly processes, etc.)
• Interface with cross functional teams (e.g., Quality, Operations, Maintenance, etc.) to understand design issues and opportunities to improve production effectiveness and efficiency
• Interface with Packaging Engineering and Operations to resolve design issues and communicate opportunities to tailor design to improve manufacturability
• Perform other duties as assigned.

Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.

Regulated Responsibilities (including cGMP and EHS)

Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Education and Experience:

Minimum requirements for this position are:

Essential Knowledge, Skills & Abilities:

• Demonstrated ability to manage projects to completion on time and within budget.
• Knowledgeable in cGMP’s for pharmaceutical processing is preferred.
• Demonstrated leadership skills to perform as a member of cross-functional work teams.
• Ability to work and interact with peers, vendors, various personnel in scientific, engineering, QA, Validation, and operational disciplines.
• Good understanding of product quality requirements and customer needs
• Strong troubleshooting skills
• Strong technical and analytical skills
• Ability to influence change
• Knowledge of Failure Analysis techniques
• Knowledgeable in Microsoft Project and Autocad
• Knowledgeable in Lean Six Sigma Methodologies
• Detail-oriented and self-motivated