Operations Engineer

at  Luminary Group

Engage: “Discover a leading global innovator in radiopharmaceuticals, specializing in the development, production, and distribution of advanced targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for cancer treatment. This company is well-regarded for its contributions to advancing precision oncology.”
Background: “Established in 2004, this company’s mission is to significantly enhance cancer treatment outcomes and improve patient quality of life through targeted radionuclide therapies. Operating worldwide, the company’s products play a crucial role in advancing precision oncology and cancer treatment.”
Recent Developments: “The company is experiencing rapid growth and is expanding its capabilities to meet rising global demand for radiopharmaceuticals. New projects are underway to increase production and delivery capacities.”
C-Level Hires: “Over the past year, the company has bolstered its leadership team with top professionals from leading pharmaceutical firms, driving robust growth and innovation in the radiopharmaceutical sector.”
Purpose: “We are currently seeking a full-time Operations Engineer (f/m/d) for a hybrid role based at our office in Freising. This role is essential for maintaining technical conditions for smooth operations and regulatory compliance, directly supporting our mission of advancing cancer treatments. The position offers an exciting opportunity within a dynamic, innovative environment.”

Job Description: As an Operations Engineer, your primary responsibilities will include:

• Establishing and maintaining technical conditions as the System Owner to meet operational and legal requirements, in collaboration with radiation protection, occupational safety, and quality assurance teams (GMP guidelines).
• Implementing measures to ensure uninterrupted operations, coordinating with technical maintenance teams.
• Analyzing and resolving technical issues, collaborating with various departments and external service providers, and developing preventive strategies.
• Minimizing downtime during repairs and maintenance through close coordination with the production team.
• Planning and executing system expansions or modifications, including approvals and qualifications.
• Contributing to new construction projects, focusing on system maintainability and robustness in cleanroom and radioactive environments.
• Providing technical and GMP-compliant documentation.
• Documenting maintenance and repair activities to support internal audits, commercial concerns, and external inspections.
• Preparing and implementing corrective actions for GMP-relevant measures, addressing deviations, and conducting investigations.
• Assisting 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.

• Establishing and maintaining technical conditions as the System Owner to meet operational and legal requirements, in collaboration with radiation protection, occupational safety, and quality assurance teams (GMP guidelines).
• Implementing measures to ensure uninterrupted operations, coordinating with technical maintenance teams.
• Analyzing and resolving technical issues, collaborating with various departments and external service providers, and developing preventive strategies.
• Minimizing downtime during repairs and maintenance through close coordination with the production team.
• Planning and executing system expansions or modifications, including approvals and qualifications.
• Contributing to new construction projects, focusing on system maintainability and robustness in cleanroom and radioactive environments.
• Providing technical and GMP-compliant documentation.
• Documenting maintenance and repair activities to support internal audits, commercial concerns, and external inspections.
• Preparing and implementing corrective actions for GMP-relevant measures, addressing deviations, and conducting investigations.
• Assisting with audits and inspections from customers and regulatory authorities