The Manager, Site Operations (cGMP Systems), is responsible for managing the maintenance of cGMP critical utilities for all buildings and clinical manufacturing equipment at the Gaithersburg Campus. This role will ensure the maximum reliability and uninterrupted supply of critical utility availability for all cGMP systems. These systems serve all areas of Research & Manufacturing.

The Manager will directly oversee all systems required for the site to maintain operations in emergency and normal operations. Leveraging industry knowledge and the collaborative relationships with end users, the manager will deploy in-house and contracted resources to operate and maintain systems in accordance with local regulations. Additionally, the manager will perform failure investigations and corrective/preventive actions, overseeing all system modifications, and improvements. This role will collaborate with the sustainability and project engineering teams to ensure efficient and effective utilization of the onsite equipment to minimize our carbon footprint while maintaining service expectations.

The Manager will evaluate new processes and technologies through consultation with external subject matter experts, to achieve cost effective and environmentally responsible. The Manager will interface with various departments to ensure processes and designs are compatible and support future process.

Oversee the maintenance and project work performed by Technicians and On-Site Service Providers work including preventive, predictive and corrective maintenance services for cGMP critical utilities systems and clinical manufacturing equipment at the Gaithersburg Campus.
Manage and support the acquisition, installation, operation, and enhancements of equipment and GMP critical utilities and clinical manufacturing equipment.
Develop, improve and optimize PMs (Preventive Maintenance) to maximize equipment uptime and performance. Track uptime and performance through metrics and KPI's
Develop a technical staff to develop high-performing work teams within their functional areas and to maintain good working relationships within the department and site customers.
Lead investigations caused by maintenance activities and support Site Operations Quality Systems team as required.
Maintain the facilities operation that advances company core values and mission.
Maintain daily awareness of technician headcount and assignments; maintain progress reports of maintenance activities and performance.
Maintain facilities compliance with OSHA and company SHE policies & procedures. Management of facilities responsibilities to support ODS, MDE, WSSC compliance.
Coordinate projects and maintenance with the Planning and Scheduling team to review Work Order (WO) scope of work, estimate costs and technician hours, plan work activities, order parts and supplies, prepare Maintenance Technician work schedule, obtain required permits (local building code, confined space, lock out tag out, hot work, and others), obtain access to building areas and notify affected occupants.
Collaborate with Planning and Scheduling team Maintenance Planner to coordinate and triage all notifications ensuring proper information is recorded. Verify all related documentation is completed prior to releasing WO. Review completed WOs for accuracy and proper documentation.
Collaborate with Materials Management team to determine stock levels, critical vs. non-critical spares, automatic ordering vs. ordering on demand.
Collaborate with other Site Operations Managers to maintain and publish work priority system for 24/7 emergency response; and establish priority system for daily scheduled and unscheduled work activities. Ensuring coverage 24/7 to direct and coordinate emergency issues that may arise from the on call technician.
Collaborate with Site Operations Quality Systems team ensuring Technicians are qualifications and learning completion percentages are kept in good standing.
Collaborate with Site Operations Project Management team on review, design, and commissioning of new capital construction projects and renovations when requested.
Ensure the accuracy and input of maintenance data into the CMMS for the tracking and reporting of maintenance metrics. Share responsibility with Maintenance Planning/ Scheduling, MRO, and SAP Administrators for implementation, management and effectiveness of the CMMS system (SAP).
Review CMMS KPI's and metrics for improvement opportunities.
Ensure systems and equipment maintained remains in fully operational condition to meet the business requirements for that space. Ensure the quality of the work performed is in accordance with company and industry standards.
Develop and manage procedures and policies that are created with partners such as Manufacturing Sciences, Soft Services, SHE, and Contract Maintenance.
Ensure that all activities are performed and documented accurately and are in compliance with SOPs, cGxP, and FDA requirements.
Ensure the appropriate level of cGxP training for all maintenance staff, following corporate guidelines and policies. Ensure maintenance technicians' qualifications and training records are on file and current.
Address and resolve CRs (Change Requests), deviations, and SOPs in responsible area of control.
Participate on project teams with other internal department members, external vendors/contractors, or customers as requested.
Identify projects that will result in additional financial savings or reductions in carbon or waste metrics for the campus

Typical Accountabilities:

Equipment Maintenance: Overseeing the maintenance and repair of production equipment and supporting utilities to ensure they meet GMP standards and regulatory requirements.
Compliance: Ensuring that all maintenance activities comply with GMP regulations, company policies, and safety standards.
Budget Management: Managing the maintenance budget, including cost control, forecasting, and optimization of maintenance resources.
Team Management: Leading and managing a team of maintenance technicians and contractors to ensure the smooth operation of manufacturing equipment.
Documentation: Maintaining accurate maintenance records, logs, and documentation to demonstrate compliance with GMP standards during regulatory inspections.
Continuous Improvement: Identifying opportunities for process and efficiency improvements within the maintenance function to enhance GMP compliance and reduce downtime.
Risk Management: Identifying and mitigating potential risks to GMP compliance within the maintenance activities, including proactive identification of equipment reliability issues.
Training and Development: Providing training and development opportunities for maintenance staff to ensure their skills and knowledge align with GMP requirements and industry best practices.
Collaboration: Collaborating with cross-functional teams, such as manufacturing, quality, and engineering, to support GMP compliance and overall operational objectives.

Other Responsibilities:

Provide guidance, direction and oversee the daily execution of technicans job duties
Build high-performing work teams
Ability to multitask and manage multiple projects concurrently.
Maintain current and thorough understanding of all utility and manufacturing equipment typically found in Pharmaceutical and Biotechnology Utility Plants, R&D Labs, Pilot Plants, and cGMP manufacturing environments.
Excellent written and verbal communication skills.
Proficient in computer skills and MS Office application suite.
Experience in maintenance trades and knowledge of building codes.
Available 24/7 to direct and coordinate emergency issues that may arise on Capital Projects.
Responsible for Change Controls, Deviations, SOPs in responsible area of control.

Education:

Bachelor's plus 5 years' relevant experience. Master's degree and 3 years' of relevant experience.

Experience:

5+ years Maintenance and Engineering or relevant experience

Special Skills/Abilities:

GMP Expertise: In-depth knowledge of GMP regulations and their application to maintenance activities within a pharmaceutical manufacturing environment.
Technical Proficiency: Strong technical understanding of pharmaceutical manufacturing equipment, including but not limited to HVAC systems, utilities, process equipment, and packaging lines.
Regulatory Compliance: Demonstrated ability to ensure and maintain compliance with regulatory requirements such as FDA, EMA, and other relevant authorities.
Change Management: Experience in managing and implementing changes in a GMP environment while ensuring compliance with regulatory standards.
Leadership and Team Management: Proven leadership skills and experience in managing a team of maintenance professionals, fostering a culture of accountability, safety, and continuous improvement.
Problem-solving: Ability to analyze complex maintenance issues, identify root causes, and implement effective solutions while maintaining GMP compliance.
Project Management: Proficiency in managing maintenance projects, including planning, execution, and resource allocation, while adhering to GMP standards.
Communication Skills: Strong communication and interpersonal skills to effectively collaborate with cross-functional teams, regulatory agencies, and external vendors.
Quality Mindset: A commitment to maintaining a strong quality mindset, ensuring that all maintenance activities align with AstraZeneca's quality and compliance standards.
Continuous Improvement: A focus on driving continuous improvement initiatives within the maintenance function, utilizing data-driven approaches and best practices to enhance reliability and compliance.
Computer Skills: Outlook, Internet Explorer, SAP, Capability to Utilize Various Programs Developed for Day to Day Operations, Specialty Maintenance PM Software, MS Office Programs (Excel, Word, Project, etc.)

Job Complexity:

Regulatory Compliance: Managing maintenance activities in a highly regulated GMP environment, ensuring strict adherence to regulatory requirements, including those set forth by the FDA, EMA, and other global regulatory agencies.
Multi-disciplinary Collaboration: Navigating and coordinating activities across multiple departments, including engineering, manufacturing, quality assurance, and regulatory affairs, to ensure seamless integration of maintenance activities with overall manufacturing operations.
Risk Management: Identifying and mitigating potential risks to GMP compliance within the maintenance function, including proactive identification of equipment reliability issues and corrective actions.
Technology Integration: Overseeing the integration of new and advanced technologies into existing manufacturing equipment while maintaining GMP compliance and ensuring minimal impact on ongoing operations.
Change Management: Effectively managing changes in equipment, processes, and systems, ensuring minimal disruption to manufacturing activities while meeting GMP requirements.
Resource Optimization: Balancing the need for proactive maintenance with the demands of a dynamic production schedule, optimizing resources to minimize downtime and maximize equipment reliability without compromising GMP compliance.
Complex Problem Solving: Addressing complex maintenance challenges while adhering to GMP standards, including the resolution of equipment failures, process deviations, and other critical maintenance-related issues.
Continuous Improvement: Driving a culture of continuous improvement within the maintenance function, utilizing data-driven approaches and best practices to enhance reliability, compliance, and efficiency.

Date Posted

30-Sep-2024

Closing Date

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AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.