Maintenance Engineer

About the job

We are seeking a skilled Maintenance Engineer to support the lifecycle of equipment and systems across our operations. The ideal candidate will have strong technical expertise in maintenance engineering as well as hands-on experience with User Requirement Specifications (URS), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Operational Qualification (OQ), and Performance Qualification (PQ).

This role is critical to ensuring equipment reliability, compliance with regulatory standards, and the successful qualification of systems used in manufacturing and quality environments. As a Maintenance Engineer, you will be involved in developing and improving our new production facility and will be directly reporting to Maintenance Manager.

Responsibilities:

• Develop, review, and maintain User Requirement Specifications (URS) for new and existing equipment.

• Coordinate and participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) with vendors and internal teams.

• Lead and execute Operational Qualification (OQ) and Performance Qualification (PQ) activities to ensure equipment meets operational and regulatory standards.

• Troubleshoot, maintain, and improve manufacturing equipment, utilities, and support systems.

• Collaborate with Quality Assurance, Validation, and Production teams to ensure adherence to GMP and industry regulations.

• Prepare technical reports, validation documentation, and maintenance records in compliance with company and regulatory requirements.

• Support continuous improvement initiatives to enhance system reliability and reduce downtime.

• Train operations and maintenance staff on validated equipment and systems.

Qualification / Background:

• Bachelor’s degree in Mechanical, Electrical or related Engineering field (or equivalent technical experience).

• Proven experience with equipment qualification and validation processes (URS, FAT, SAT, OQ, PQ).

• 3+ years of experience in a GMP-regulated industry (pharmaceutical, biotechnology, or medical devices preferred).

• Strong understanding of maintenance engineering principles, reliability practices, and root cause analysis.

• Familiarity with regulatory requirements (FDA, EMA, ISO standards) and good documentation practices.

• Excellent problem-solving, project management, and communication skills.

• Ability to work cross-functionally with vendors, QA, validation, and production teams.

• Knowledge of maintenance management methods, of predictive inspection tools

• Excellent command of written & spoken English

• Good command of MS Office programs

• Experience in technical 3D drawing software (AutoCAD Inventory, SolidWorks etc.)

• Preferably knowledgeable in ERP systems

• Strong communication and coordination skills

• Good problem solving, planning and follow up abilities for a sustainable relationship with suppliers

• Teamwork oriented with multiple stakeholders

• No military obligation