General Position Summary:
Zymergen is adding to its Facilities team a Facilities Coordination Manager to manage activities for the department. The ideal candidate will implement best practices to streamline compliance operations within the facility department. This individual performs documentation reviews thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
The position is responsible for providing a wide range of critical support for facilities services in the Maintenance Business Office. The focus of the position will be coordination of planned, and unplanned work, planning, scheduling, and communication of non GxP work orders across multiple buildings, the future focus is to have these activities to meet GLP standards.
Responsibilities include; revise maintenance schedules, update task lists, print monthly reports and track maintenance requests; uploads CMMS data and supporting documents to maintenance software; maintain CMMS physical files, organize existing and new as-built drawings, project turnover documents and equipment manuals in both electronic and hard copy files, work with procurement to assist in renewing equipment service contracts with mechanical, electrical, and plumbing maintenance vendors; maintain a drawing system for all projects, and any turn over documents.
The position will maintain, and track Mechanical and Life Safety Regulatory Permit process for properties; Maintain Environmental Protection Agency (EPA) and Department of Environmental Protection (DEP) reports like air permits, wastewater discharge permits and backflow preventer inspections; Review and update company guidelines, procedures.
Key Accountabilities/Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and Procedures:
- Reviews deviations, investigations, and CAPAs associated with cGxP compliance. Supports change controls related to Quality topics.
- Writes new documents and revises existing documents, independently.
- Develops and provides training on department-specific procedures and systems.
- Participates in internal or supplier audits as needed.
- Maintenance of the Equipment Qualification and Equipment Maintenance / Calibration Program.
- Train employees on Quality and Facilities Systems and Procedures.
- Served as a backup for Director of Facilities Engineering on QA Management review for Deviations, Change request, CAPA.
- Assigned and reviewed Calibration, Maintenance, and Unscheduled Work Orders to the Facilities Group and outside vendors.
- Create, edited, word processed, and routed SOPs.
- Represented the Facility department in cross-functional groups to assist in developing new and efficient systems for the department and in GXP related activities.
- Providing a clear understanding of the Core Technology quality management system requirements (provided by standards, business partners, and regulations)
- Writing defensible rationales that follow good technical writing practices (background, supporting evidence, broader justiﬁcation and a decisive conclusion)
- Participating in selection, qualification, and management of suppliers and service providers
- Preparing for and participating in customer, third party, or regulatory audits
- High School Diploma
- 5 years’ experience working in a Facilities related environment
- S. in in a Life Sciences discipline or At least 2 years of quality-related experience within an ISO or GXP environment
- Basic hazardous materials training desirable
- Previous experience leading a small team and supervising and guiding technical staff
- Proven ability to manage multiple tasks, prepare metrics and meet deadlines.
- Understands and applies comprehensive knowledge of quality and GxP principles.
- Maintains current understanding of global GLP regulations.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management.
- Experience with supplier quality systems and performing internal audits
- Solid understanding of GxP utility systems and manufacturing process equipment.
- Strong working knowledge of GxP compliance requirements related to maintenance operations.
- Computer proficiency on CAD, Word, Excel, Power Point, Outlook, and Microsoft Project preferred.
- Previous experience with CMMS (Computerized Maintenance Management System) EMS (Environmental Monitoring System) and BMS (Building Automation Systems) is a plus.
- Experience working within QA Released Documents, Engineering Change Request, Corrective action and CAPA systems
Founded in 2013 and based in the San Francisco Bay Area, Zymergen is a technology company unlocking the power of biology. We deliver better economics for products made from biology that are used across industries, bring new products to market faster, and develop novel products. Our proprietary platform uses robots and machine learning to engineer microbes faster, more predictably, and to a level of performance previously unattainable. These microbes, and the products they produce, have broad applications across industries such as chemicals and materials, agriculture, and healthcare. For more information visit www.zymergen.com.