Engineering Manager — GMP Production & Equipment Lead

Aurora Pharmaceutical Inc; Northfield (MN); On-site; USD 130,000 - 185,000; Full time

Job summary

Aurora Pharmaceutical Inc. is seeking an experienced Engineering leader to design and install pharmaceutical processes in a cGMP environment and drive solutions that ensure continuous equipment operation. You will manage IQ, OQ, PQ and validations while leading an Engineering team.

The role covers installation, maintenance, SOP creation, drawings, quality attributes control, calibrations and preventive maintenance, with strong cross-functional collaboration and a continuous improvement mindset.

Qualifications

• 5+ years knowledge in the Engineering, Operations and Production areas of a pharmaceutical GMP production environment
• 5+ years in a management role leading an Engineering team

Responsibilities

• Oversees the installation, operation and maintenance of production equipment
• Trains other employees on proper use and setup of machines and equipment
• Complies with established standard operating procedures, cGMP quality standards and regulatory procedures
• Creates and updates SOPs (Standard Operating Procedures)
• Creates and updates equipment and facility drawings
• Determines how key quality attributes can be influenced by processing and can be controlled
• Assists with new equipment installations
• Writes and executes IQ, OQ, and PQs
• Writes and executes validations
• Sets up calibrations
• Sets up PMs (Preventive maintenance)
• Precisely follows work orders and specifications
• Adheres to all plant safety policies and procedures
• Effectively communicates with other production employees and with all levels of management
• Collaborates in cross functional teams
• Flexible and open minded to suggestions from others; keen vision for continuous improvement
• Meets the following physical requirements: Stands, walks 50% of the time
• Repeatedly lifts or pushes a cart with 30-70 lbs
• Performs other duties as requested

Skills

Engineering

Operations

Production GMP

Management

Team leadership

Education

Bachelor's Degree in Engineering

Job description

Aurora Pharmaceutical Inc. is seeking an experienced Engineering leader to design and install pharmaceutical processes in a cGMP environment and drive solutions that ensure continuous equipment operation. You will manage IQ, OQ, PQ and validations while leading an Engineering team.

The role covers installation, maintenance, SOP creation, drawings, quality attributes control, calibrations and preventive maintenance, with strong cross-functional collaboration and a continuous improvement mindset.