GMP Engineering Specialist

About the role

In this role you will be responsible for assisting Engineering, Maintenance, and Validation with quality support as it relates to CMMS administration, change control, equipment non-conformances, equipment deviations, routine maintenance plan updates, technical document creation, and alarm response tracking and reporting. This position is located at the 3300 South Second Street facility.

Responsibilities

• Coordinate validation, maintenance, and engineering documentation and operational tasks.
• Author technical reports, quality records, maintenance plans, and Facility/Equipment Operating Procedures.
• Manage Change Controls, Deviations, and CAPAs in the QMS across cross-functional teams (Engineering, QA, Manufacturing, Validation).
• Manage equipment/facility investigations, troubleshooting, root cause analysis, and risk assessments.
• Maintain CMMS by updating records, creating new equipment/calibration plans, and generating, reviewing, and closing work orders in compliance with cGMP.
• Support equipment commissioning, qualification, validation, and preventative maintenance shut-down activities.
• Track alarm responses and prepare quarterly operational reports.
• Assist with internal, customer, and regulatory audits, providing on-the-floor oversight and building management system monitoring during shutdowns.

Qualifications

Minimum Qualifications:

• Associate Degree in Chemistry, Biology, Controls Engineering, Mechanical Engineering or other Life Science or Engineering Discipline.
• OR Vocational degree or certification in industrial maintenance, electronics, or other trade and 1+ years of experience in a GMP manufacturing industrial role.
• OR High School Diploma or GED and 3+ years of experience in a GMP manufacturing industrial role.

Preferred Qualifications:

• Bachelor’s Degree in Engineering or Science discipline.
• 2+ years of experience in cGMP Quality, Engineering, or Manufacturing.
• Experience with TrackWise, Mango, SAP or other QMS and CMMS systems in cGMP environment.
• Ability to work within a cross-functional team.
• Effective oral and written communication skills.
• Demonstrated use of Good Documentation Practices.
• Strong computer and document management skills with sharp attention to detail.

Pay

$31 - $48 / hour. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other prerequisites