Facilities Engineer

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Facilities Maintenance Engineer/Specialist is a critical role within our Facilities team, responsible for ensuring the smooth operation of our facilities through effective maintenance, project management, and support activities. This role requires a blend of technical expertise and operational excellence, ensuring our facilities are compliant, efficient, and aligned with our organizational goals. Responsibilities

Manage and utilize the IFS/Computerized Maintenance Management System (CMMS) for accurate asset data management, including calibration and preventive maintenance schedules. Coordinate and support validation activities, ensuring compliance with industry standards. Oversee and manage small to medium-scale projects, focusing on facility improvements and efficiency enhancements. Implement and manage the Qualer system, ensuring optimal utilization for maintenance and calibration activities. Conduct spare parts assessments and manage inventory to support ongoing facility operations. Organize and improve facility upkeep, focusing on mechanical areas and grounds maintenance. Manage work order documentation from initiation to closure, ensuring compliance with Good Documentation Practices. Prioritize and plan safety-related work orders, maintaining a safe working environment. Develop and action metrics for facility maintenance, driving continuous improvement. Handle deviations, CAPAs, and audit actions, ensuring timely resolution and compliance. Act as the site SME for IFS, providing guidance and support to the facilities team. Qualifications

BS in Engineering, Facilities Management, or a related field. 3 to 5 years of experience in a GMP manufacturing or other regulated industries. Demonstrated ability to assess and improve maintenance and asset management processes. Strong documentation skills, adhering to Good Documentation Practices. Excellent communication and interpersonal skills, facilitating effective cross-functional collaboration. Familiarity with FDA, EudraLex, and ISO regulations related to GMP manufacturing. Proficiency in MS Office Suite and experience with equipment/asset management databases. Abzena is an Equal Opportunity Employer:

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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