The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
About the Team
Sterigenics is a leading global provider of outsourced terminal sterilization services for the medical device, pharmaceutical, food safety and advanced applications markets. With our industry recognized expertise we help to ensure the safety of millions of patients around the world every year. Across our 48 global facilities, we offer our customers a complete range of sterilization services, primarily using the three major technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation. We are committed to addressing the growing need for sterilization across the world and partnering with our customers to eliminate threats to human health. Learn more about Sterigenics at www.sterigenics.com
Safeguarding Global Health® - with every product we sterilize.
Maintenance
- Manage the department
- Organization and execution of all maintenance planning required for a trouble-free technical operating process, as well as maintenance, repair and calibration work, taking into account resources, so that the operating equipment used can fulfill its intended purpose optimally and in accordance with safety requirements at all times.
- Preparation of maintenance and calibration plans according to standards and rules, supplier specifications or internal specifications with determination of time intervals for the respective maintenance and calibration.
- Issuance of the work permit to internal personnel and external companies (coordinator in accordance with § 9.1. Code of Practice M045 of BG Chemie) after implementation of the required safety measures, especially for work in gas-contaminated areas.
- Preparation and maintenance of maintenance documentation in accordance with ISO 9001.
- Implementation of accident prevention and occupational safety concerns in the department
- Cost control
- Participate in management meeting, ASA meetings, management review meeting and audits.
Production
- Manage the department
- Develop and implement operational strategies and objectives to ensure the organization meets its goals
- Develop a strategic plan to increase efficiency and performance within the department
- Planning, implementation and documentation of annual instructions/training of subordinate employees in occupational health and safety.
- Planning and implementation of occupational health check-ups in consultation with the Human Resources department
- Ensure inspections of work equipment and facilities and their documentation on time
- cooperate with special functionaries such as the company physician and the occupational safety specialist
- Take health and safety into account in planning and procurement
- Involve and inform external companies
- integrate temporary employees
- Ensure first aid and emergency response (including designation and training of first responders in the department).
- To appoint a safety officer for their department
Head of production in accordance with § 14 of the German Medicines Act and § 12 of the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients. Responsibility for GMP in accordance with the provisions of the German Drug and Active Ingredient Manufacturing Ordinance:
- Ensuring that products are manufactured and stored in accordance with the relevant instructions in order to maintain the required quality
- Approving the instructions for the manufacturing processes and ensuring that these are strictly adhered to
- Ensuring that the manufacturing records are checked and signed by an authorized person before they are passed on to the quality control department
- Checking the maintenance, premises and equipment of his department
- Ensure that the necessary validations are carried out
- Ensuring that the necessary initial and ongoing training of his department's personnel is carried out and adapted as required
Knowledge/Education and Training:
- Industrial engineer or equivalent by experience
- Master craftsman certificate (advantageous)
- Good knowledge of German and English (written and oral)
- Knowledge and experience in modern quality systems and ISO standards
- Knowledge of occupational safety and accident prevention
Experience:
- Several years of proven experience as a Head of operations/Maintenance or a similar leadership role
- Experience in employee management
- Good computer skills
- Experience in industrial control systems
Skills:
- Organizational skills
- Analyzing, integrating and concept building capacity
- Quality awareness
- Strong leadership and team management abilities
- Ability to convince, motivate and engage
- Excellent organizational and communication skills
- Ability to work under pressure
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