Operations Specialist

vor 4 Wochen

Freising, Bayern, Deutschland Luminary Group Vollzeit

Job Summary

We are seeking a skilled Operations Engineer to join our team at Luminary Group. As an Operations Engineer, you will play a crucial role in maintaining technical conditions for smooth operations and regulatory compliance, directly supporting our mission of advancing cancer treatments.

Key Responsibilities

  • Establish and maintain technical conditions as the System Owner to meet operational and legal requirements, in collaboration with radiation protection, occupational safety, and quality assurance teams.
  • Implement measures to ensure uninterrupted operations, coordinating with technical maintenance teams.
  • Analyze and resolve technical issues, collaborating with various departments and external service providers, and developing preventive strategies.
  • Minimize downtime during repairs and maintenance through close coordination with the production team.
  • Plan and execute system expansions or modifications, including approvals and qualifications.
  • Contribute to new construction projects, focusing on system maintainability and robustness in cleanroom and radioactive environments.
  • Provide technical and GMP-compliant documentation.
  • Document maintenance and repair activities to support internal audits, commercial concerns, and external inspections.
  • Prepare and implement corrective actions for GMP-relevant measures, addressing deviations, and conducting investigations.
  • Assist with audits and inspections from customers and regulatory authorities.

Requirements

  • A completed engineering degree in Pharmaceutical, Process Engineering, Mechanical Engineering, or a related field.
  • Ideally, experience in maintenance management within a pharmaceutical setting.
  • Strong proficiency in German and English, both spoken and written.
  • A structured, organized working style, with excellent communication skills for effective collaboration with service providers, authorities, and internal departments.
  • The ability to work flexibly and efficiently, with strong problem-solving abilities.

What We Offer

  • Engaging challenges in a rapidly growing company with significant creative freedom.
  • An open, international work environment with short communication paths.
  • A comprehensive onboarding program and flexible working hours, including the option for home office work.
  • Attractive special payments and employee benefits, including:
    • Employee participation programs
    • Company bike or public transport subsidies
    • Above-average pension contributions
    • Tailored training programs (including German and English courses)
    • Health promotion offers, such as fitness subsidies, sports event support, and lifestyle coaching.

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