Industry: Pharmaceutical

Key Responsibilities:

• Maintains systems that support the monitoring of key performance indicators such as yield, nonconforming material, or lead time. If indicators show an adverse trend, works with the functional team to plan and implement appropriate changes.
• Requires work in a controlled access environment and adherence to medical device manufacturing standards and regulations.
• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
• Uses basic statistical tools.
• Performs installation/validation activities for new or existent production lines, meeting regulatory requirements. That includes equipment, process, product, and test method validations.
• Identifies, selects, and purchases equipment/fixtures according to production requirements, due to obsolescence, redundancy, or line capacity expansion.
• Has direct relation with vendors to define equipment suitability.
• Keeps equipment operational by coordinating calibration, maintenance, and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.
• Has knowledge and expertise on product requirements and specifications.
• Understands potential risks related to product malfunctions.
• Assures that production lines output meet the specifications of the product.
• Has clear criteria of conforming/non-conforming product and the test methods used for verifying conformance.
• Maintains manufacturing systems such as SAP routers and BOM's current.
• Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them.
• Supports DL's & IDL's training process.
• Leads or supports local cross-functional team activities.
• Participates in the identification and investigation of Non-conforming products. Uses Root Cause Problem-Solving techniques to identify and eliminate causes, implements controls, and defines preventive activities.

Qualification: 

• Bachelor's of Engineering or similar Medical device engineering experience is a must.
• Preferred experience in medical device manufacturing.
• 2-4 years exp required.