Senior Maintenance Compliance Engineer - GMP & RCFA Expert

Scorpion Therapeutics; Michigan; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Bonus 10%

401(k) matched

Paid vacation

Leave policy

Medical/dental/vision

Job summary

Scorpion Therapeutics in Michigan is seeking a Senior Maintenance Compliance Engineer to support maintenance, reliability, and utilities systems across production and non-production equipment. You will develop scope of work, plans, perform RCFA investigations, and ensure adherence to cGMP and aseptic practices.

You will partner with Production and Quality, review preventive/corrective work orders, lead safety initiatives, and manage engineering documentation.

Qualifications

• Experience with RCFA, Equipment Criticality Ranking, PM/PDM optimization, and/or FMEA.
• Manufacturing/reliability/plant/project engineering experience.
• Strong written and oral communication and teamwork skills.
• MS Office and cGMP knowledge.

Responsibilities

• Manage maintenance/compliance engineering activities; contribute to project completion and plan short/mid-term work.
• Develop scope of work, project execution plans, and engineering studies for equipment installation or modification; provide operational support.
• Review preventive/corrective work orders; analyze maintenance history; improve PM.
• Manage technical writing and document review.
• Ensure maintenance/engineering compliance with (Current) Good Manufacturing Practices (GxP) and best aseptic practices.
• Participate in RCFA investigations; update equipment reliability plans.
• Partner with Production and Quality for troubleshooting and scheduling.
• Lead/participate in safety initiatives, safety assessments, investigations, change controls, and CAPA implementation for the maintenance department.
• Liaison between Quality Operations and engineering/maintenance to close investigations; support SOP improvements/updates.

Skills

RCFA

FMEA

PM/PDM optimization

Equipment reliability

cGMP knowledge

MS Office

Communication

Teamwork

Training abilities

Project engineering

Education

Bachelor's degree

Job description

Scorpion Therapeutics in Michigan is seeking a Senior Maintenance Compliance Engineer to support maintenance, reliability, and utilities systems across production and non-production equipment. You will develop scope of work, plans, perform RCFA investigations, and ensure adherence to cGMP and aseptic practices.

You will partner with Production and Quality, review preventive/corrective work orders, lead safety initiatives, and manage engineering documentation.