Associate Engineer

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:

• Can be assigned to work on document updates, validation activities support and direct manufacturing interaction.
• Provide direct support to manufacturing lines.
• Ensure Process instructions are accurate, effective and support compliance with applicable regulations.
• Develop preventive maintenance strategy and instructions and implement.
• Equipment and Process performance metrics (ex. Yield, Downtime, OEE, etc.).
• Change control assessment and requirements.
• Review / Revise Procedures (SOP) related to process and equipment.

Qualifications:

• Bachelor Degree in Engineering
• Experience operating in a regulated environment, preferably medical devices.
• Technical Writing Knowledge.
• Investigation and Root Cause Skills (Problem Solving Knowledge).
• Process Validation and Computer software validation knowledge.