Work Schedule Standard (Mon-Fri)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionJoin 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.
