Equipment Engineer

Get 360Pharma; Leiden; On-site; EUR 55,000 - 85,000; Full time

Job summary

Get 360Pharma in Leiden, Netherlands is seeking an Equipment Engineer to act as system owner for assigned equipment and drive lifecycle, asset management, and maintenance governance. You will lead installation, qualification, validation, and ongoing operation of equipment and systems, ensuring GMP compliance and robust documentation.

You will collaborate with Operations, Engineering, Quality, and other stakeholders to support production needs while driving improvements in safety, quality,

Qualifications

• Bachelor-level HBO degree with at least 3 years of relevant experience in a regulated environment.
• Experience as system owner or equipment engineer with lifecycle management responsibilities.
• Experience introducing new equipment or systems, including validation and user requirements.
• Familiarity with GMP, data integrity, audits, and documentation practices.

Responsibilities

• Act as system owner and SME for assigned equipment and systems, supporting lifecycle management and maintenance governance.
• Lead installation, qualification, validation, and ongoing operation of new equipment and systems.
• Maintain asset data, identify risks, and align maintenance plans with production schedules.
• Investigate equipment failures via root cause analysis and drive cross-functional improvements.
• Ensure GMP compliance and maintain documentation, SOPs, and audit readiness.
• Support training, Gemba walks, and safety, quality, reliability, and scheduling improvements.

Skills

Equipment lifecycle management

Asset management

Maintenance governance

GMP compliance

Root cause analysis

Stakeholder management

Data analysis

MS Office

Education

HBO degree (or equivalent)

Tools

Documentation systems

Job description

We are searching for the best talent to join us as an Equipment Engineer in Leiden, Netherlands.

Purpose:
In this role, you will act as an experienced support individual contributor and subject matter expert for equipment, systems, projects, processes, and improvements. You will collaborate with management, operations, and cross-functional partners to support decisions related to equipment lifecycle, asset management, system ownership, maintenance planning, and operational efficiency. You will help introduce and implement new equipment and systems, support validation and user requirements, and ensure that maintenance schedules are aligned with production needs. The role also includes ownership of equipment-related topics, including asset data, documentation, investigations, CAPA, and continuous improvement, while maintaining high standards of GMP, quality, safety, professionalism, and independent judgment.

You will be responsible for:

• Acting as system owner and subject matter expert for assigned equipment and systems, supporting equipment lifecycle management, asset management, maintenance governance, and operational efficiency.
• Supporting the introduction, implementation, installation, qualification, validation, and ongoing operation of new equipment and systems, including defining and managing user requirements.
• Leading asset management activities, maintaining asset data, identifying equipment risks and replacement needs, and ensuring maintenance plans align with production schedules.
• Investigating equipment failures, downtime, and performance issues through root cause analysis, while driving sustainable improvements with cross-functional teams.
• Ensuring GMP compliance and maintaining equipment documentation, including data integrity requirements, SOPs, work instructions, periodic reviews, and audit readiness.
• Acting as SME for equipment-related non-conformances, CAPAs, change controls, inspections, audits, and escalation of complex equipment issues.
• Supporting operator and equipment-specific training programs, conducting Gemba walks, and driving improvements in safety, quality, reliability, cost, and scheduling.
• Collaborating effectively with Operations, Engineering, Quality, and other stakeholders to support business objectives while promoting an inclusive, accountable, and continuously improving culture.

Qualifications / Requirements:

• Relevant HBO (or equivalent) degree with at least 3 years of relevant experience.
• Experience as a system owner, business system owner, or equipment engineer within a regulated environment is preferred.
• Experience introducing new equipment or systems, including implementation, qualification, validation, user requirements, and lifecycle management.
• Affinity with or experience supporting freezer systems is desirable.
• Knowledge equipment compliance, documentation requirements, data integrity, inspections, audits, and quality systems.
• Advanced analytical and problem-solving skills with the ability to identify root causes, interpret data, manage complexity, and develop effective solutions.
• Strong stakeholder management, communication, teamwork, and leadership capabilities, including coordinating initiatives and maintaining alignment across functions.
• Proficiency with MS Office, business applications, and data analysis tools, combined with a proactive, organized, accountable, quality-focused, and resilient working style.

Preferred Skills:

• Accelerating, Communication, Detail-Oriented, Execution Focus, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Management Tools, Project Support, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy