GMP Engineering Specialist

About the Role

• This position is located at the MilliporeSigma facility at 3300 South Second Street.
• This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Key Responsibilities

• Assist Engineering, Maintenance, and Validation with quality support related to CMMS administration, change control, equipment non-conformances, equipment deviations, routine maintenance plan updates, technical document creation, and alarm response tracking and reporting.
• 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 a 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.

Compensation & Benefits

• Pay Range: $31 - $48 / hour
• 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 include health insurance, paid time off (PTO), retirement contributions, and other prerequisites.