Maintenance Engineer

Stark Pharma Solutions Inc; Lansing (MI); On-site; USD 80,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Maintenance Engineer in Michigan with 5–8+ years of experience in pharmaceutical maintenance, engineering, equipment qualification, or equipment compliance.

The role supports maintenance programs, equipment compliance, risk assessments, GMP documentation, and manufacturing readiness within a regulated pharmaceutical environment. Responsibilities include reviewing PM programs, work orders, risk assessments, and documentation; identifying gaps and

Qualifications

• Bachelor’s degree in engineering or related field required.
• 5–8+ years of pharmaceutical maintenance/engineering experience required.
• Experience with GMP maintenance and aseptic manufacturing equipment preferred.

Responsibilities

• Review site maintenance programs and PM plans for GMP compliance and effectiveness.
• Review work orders for completeness and data integrity.
• Perform equipment risk assessments for manufacturing lines.
• Identify gaps in equipment maintenance and compliance; develop fit-for-use processes.
• Support equipment qualification and GMP documentation activities.
• Collaborate with Engineering, Quality, Maintenance and Manufacturing teams to resolve issues.

Skills

Maintenance engineering

GMP knowledge

Data integrity

Risk assessment

Equipment qualification

Education

Bachelor's degree in Engineering or related field

Tools

Maximo CMMS

Job description

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

Maintenance Engineer

Location

Michigan

Pay Rate

Long Term

Job Overview

We are seeking a Maintenance Engineer with 5 8+ years of experience in pharmaceutical maintenance, engineering, equipment qualification, or equipment compliance. The role will support maintenance programs, equipment compliance, risk assessments, GMP documentation, and manufacturing readiness within a regulated pharmaceutical environment.

Key Responsibilities

• Review site maintenance programs, preventive maintenance plans, and maintenance frequencies for effectiveness and GMP compliance.
• Review executed work orders for completeness, documentation practices, and data integrity.
• Perform risk assessments for manufacturing equipment and production lines.
• Identify equipment, maintenance, and compliance gaps and associated risks.
• Develop processes to confirm equipment is compliant and fit for use before release into manufacturing.
• Support equipment qualification and compliance activities.
• Review maintenance documentation and identify areas for improvement.
• Work with Engineering, Quality, Maintenance, and Manufacturing teams to resolve compliance issues.

Required Qualifications

• Bachelor s degree in Engineering or a related field.
• 5 8+ years of experience in pharmaceutical maintenance, engineering, equipment qualification, or equipment compliance.
• Pharmaceutical GMP maintenance or engineering experience.
• Experience with sterile injectable or aseptic manufacturing equipment.
• Experience with equipment such as washers, tunnels, fillers, cappers, CIP, SIP, parts washers, autoclaves, HVAC, and utilities.
• Experience reviewing PM programs, maintenance frequencies, work orders, and maintenance documentation.
• Experience performing equipment and process risk assessments.
• Strong understanding of GMP documentation and data integrity.

Experience With Maximo Or Other CMMS Platforms Is Preferred.

Strong troubleshooting and problem-solving skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.