Maintenance Engineer

Maintenance Engineer voor clean utilities in de farmaceutische industrie, Leiden, tijdelijk.

Locatie
Leiden
Werkvorm
op locatie
Sluitingsdatum

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Eisen

  • Bachelor's degree or equivalent, preferably with a technical background
  • Excellent communication skills in English
  • Experience with GMP systems, WDI/WFI systems, and control strategies (BMS)
  • Minimum of 2 years' experience in a regulated pharmaceutical or GMP environment
  • Knowledge of assets management within pharma
  • Strong problem-solving skills and attention to detail
  • Proficiency in reading and editing P&IDs

Wensen

  • SAP PM or similar CCMS system knowledge
Volledige omschrijving

We are working with a global leader in innovative medicine, committed to developing life-changing treatments. Their focus is on delivering high-quality, custom-made medicines that make a real difference in patients' lives. The company fosters a dynamic and collaborative environment, encouraging professional growth and innovation. We are seeking a dedicated Maintenance Engineer to support the maintenance and reliability of clean utilities systems essential to pharmaceutical manufacturing.

This temporary role involves ensuring the operational readiness and compliance of water systems used in production, contributing to the safe, efficient, and compliant manufacturing processes.

Responsibilities: Support the Business System Owner (BSO) for clean water systems (WFI, WDI) and related Building Management and Environmental Monitoring systems. Manage the GMP water, BMS, and EMS asset packages to ensure optimal availability and performance of facilities. Collaborate with maintenance and engineering teams on long-term investment planning, including CAPEX proposals. Present investment plans during budget cycles, providing input from the BSO.

Participate in change management processes during design, commissioning, and qualification stages, assessing impact and feasibility. Support installations to meet reliability and quality standards, ensuring GMP compliance. Identify activities needed for successful implementation and carry out these tasks if applicable. Contribute to engineering projects and oversee handovers to ensure system readiness and compliance. Ensure adherence to all regulatory requirements and Johnson & Johnson standards, including GMP and EHS policies.

Requirements: Bachelor's degree or equivalent, preferably with a technical background. Minimum of 2 years' experience in a regulated pharmaceutical or GMP environment. Knowledge of assets management within pharma. Experience with GMP systems, WDI/WFI systems, and control strategies (BMS). Proficiency in reading and editing P&IDs. Strong problem-solving skills and attention to detail. Excellent communication skills in English. SAP PM or similar CCMS system knowledge is advantageous.

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Maintenance Engineer

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