Engineering Manager

The International Society for Pharmaceutical Engineering, Inc.; Northfield, Northern (MN, KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Aurora Pharmaceutical, LLC is seeking an Engineering Manager in Minnesota to lead the design and installation of pharmaceutical processes in a cGMP setting. You will manage equipment operations and drive continuous improvements, ensuring IQ/OQ/PQ validations are executed and SOPs are maintained.

The role requires a Bachelor’s degree in Engineering and 5+ years in pharma GMP environments, including management of an engineering team.

Qualifications

• Bachelor’s degree in engineering required.
• 5+ years in engineering/operations in pharma GMP environment.
• 5+ years in a management role leading an engineering team.

Responsibilities

• Oversees installation, operation and maintenance of production equipment.
• Develops and leads an engineering team of varying skill levels.
• Investigates equipment failures and recommends improvements.
• Trains employees on machines and equipment setup.
• Ensures SOPs, cGMP standards and regulatory procedures are followed.
• Creates/updates SOPs and equipment/facility drawings.
• Writes and executes IQ, OQ, PQ and validations.
• Sets up calibrations and PMs.
• Communicates effectively with all levels of management.
• Collaborates in cross-functional teams and supports continuous improvement.

Skills

Engineering management

GMP knowledge

IQ/OQ/PQ validations

Process improvement

Equipment installation/maintenance

Team leadership

SOP writing

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering

Job description

Engineering Manager

Reports to: COO

Position Purpose

Effectively manage the design and installation of pharmaceutical processes in a cGMP environment. Develops and implements solutions to insure continued and efficient equipment operations. Participates in process improvement initiatives related to equipment and processes. Efficiently manages the process of IQ, OQ, PQ and validations.

Job Responsibilities (*denotes essential job function)

• Oversees the installation, operation and maintenance of production equipment *


• Develops and leads an Engineering team of various skill levels*


• Investigates equipment failures and difficult to diagnose faulty operations and makes recommendations for improvement*


• 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*


• Promotes a positive can-do attitude*


• Collaborates in cross functional teams*


• Flexible and open minded to suggestions from others; keen vision for continuous improvement.


• Consistently follows all company policies & procedures.

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

Qualifications - Education and Experience

• Bachelor’s Degree in Engineering


• 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

This job description is subject to change at the sole discretion of Aurora Pharmaceutical, LLC.