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von: Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Join us as a skilled Facility Asset and Compliance Engineer in Allschwil.
Key Responsibilities:
Asset Management:
- Use the IBM Maximo asset management system to monitor, track, and maintain records of all facility assets, equipment, and systems.
- Develop and implement asset maintenance strategies, including preventive and corrective maintenance plans, to ensure efficient performance and longevity of assets.
- Collaborate with multi-functional teams to schedule and implement routine maintenance, calibration, and repairs of critical equipment to minimize downtime and disruptions.
- Conduct periodic asset inspections and assessments to identify potential issues and recommend improvements for efficient operation.
Compliance Management:
- Lead compliance efforts by effectively using Trackwise or similar systems for documenting and managing deviations, change controls, and CAPAs (Corrective and Preventive Actions).
- Collaborate with Quality Assurance and Regulatory Affairs teams to ensure facility operations meet GMP regulations, ensuring quality and safety.
- Drive the review and approval process for deviations and change controls, ensuring timely implementation of corrective actions.
- Collaborate with relevant departments to investigate deviations and implement corrective actions to prevent recurrence.
Document Control:
- Regularly review and update facility-related Standard Operating Procedures (SOPs) and Work Instructions in accordance with evolving regulations, standard methodologies, and operational requirements.
- Maintain an organized and up-to-date repository of facility-related documents for easy accessibility.
- Collaborate with team members to develop and revise SOPs and Work Instructions to improve operational efficiency and compliance with GMP standards.
Continuous Improvement:
- Find opportunities for process improvements, using data-driven approaches to optimize operations and improve efficiency.
- Stay updated with industry trends and regulations related to GMP facilities, asset management, and compliance.
Qualifications:
- Bachelor’s degree in engineering, Facilities Management, or a related field or equivalent experience. Master's degree or equivalent experience is a plus.
- Proven experience in facility management, asset management, and compliance within GMP-regulated environments.
- Proficiency in using IBM Maximo or similar Computerized Maintenance Management System (CMMS) for asset management.
- Strong understanding of GMP regulations and compliance requirements, including experience with Trackwise or equivalent deviation and change control systems.
- Excellent analytical skills with the ability to analyze data, identify trends, and propose data-driven solutions.
- Strong communication skills in German and English and the ability to collaborate effectively with multi-functional teams.
- Diligent approach with a dedication to maintaining accurate and up-to-date documentation.
- Consistent track record of driving continuous improvement initiatives in facility management practices.
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