Engineering Manager - GMP/Pharma Operations

AMERICAN REGENT, INC.; New Albany (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

American Regent, Inc. in Ohio is seeking a Manager to lead the Engineering Department, oversee facility, utility, lab and manufacturing equipment, and act as SME for design, construction and commissioning under FDA and GMP guidelines.

You will chair meetings, drive cross-functional projects, and communicate with leadership throughout the organization, ensuring compliant engineering practices and continuous improvement.

Qualifications

• Bachelor's Degree in Engineering is required.
• Minimum 8 years of experience in Pharmaceutical or similar regulated environment.
• Minimum 5 years leadership experience.
• Proficient with Microsoft Office Applications, including Project, Word, and Excel.

Responsibilities

• Manage Engineering Department and oversee staff.
• Prepare, maintain, and follow procedures for design, construction, and commissioning to cGMP standards.
• Develop, review, revise, and maintain SOPs for all Engineering processes.
• Coordinate Engineering activities and scheduling of work.
• Provide technical troubleshooting and SME for engineering systems.
• Support QA investigations and change control.
• Ensure facilities and utilities drawings are up-to-date.

Education

Bachelor's Degree in Engineering

Tools

AutoCad

Microsoft Project

Microsoft Word

Microsoft Excel

Job description

American Regent, Inc. in Ohio is seeking a Manager to lead the Engineering Department, oversee facility, utility, lab and manufacturing equipment, and act as SME for design, construction and commissioning under FDA and GMP guidelines.

You will chair meetings, drive cross-functional projects, and communicate with leadership throughout the organization, ensuring compliant engineering practices and continuous improvement.