GMP Engineering Manager: Lead Pharma Equipment & Validation

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

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.