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Manager, Clinical Maintenance

My company shares my
passion for helping to improve
human health around the world.”

“This is My MedImmune.”
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.

Title: Manager, Clinical Maintenance
Location: MD, Gaithersburg - Corporate Headquarters
Req: 01947

Position Summary:
Responsible for managing the design and implementation of office, manufacturing, research processes, instrumentation and equipment from the laboratory through pilot plant and manufacturing scale. Plans, budgets and schedules facility modifications including estimates on equipment, labor, materials, utilities and other related costs. Develops and implements annual departmental expense/capital plans. Provides expertise in office, research, manufacturing, engineering, design and process design/scale-up. Assists the manufacturing/research operations in problem solving with regards to equipment and systems. Develops capital expenditure requirements and documentation to purchase/install new systems/equipment/processes. Develops and recommends new processes and technologies to achieve cost effectiveness and improved product quality. Recommends processes for the production of therapeutic products. Establishes operating equipment specifications and improves manufacturing techniques. Involved in new product scale-up, process optimization, technology transfer, and process validation activities. Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology. Supports company growth with space optimization and construction management for new/renovated manufacturing, research and administrative areas. Oversees the coordination of building space allocation and layout, communication services and facilities expansion.


Essential Job Functions:
Carries out managerial responsibilities in accordance with organizational policies, procedures, and state, federal and local laws. Oversees and manages departmental activities in regards to both planned and unplanned maintenance utilizing a Computerized Maintenance Management System such as Maximo. Ensures that all department activities are performed and documented accurately and are in compliance with SOP’s, cGXP, and FDA requirements (cGMP). Assures the appropriate level of cGMP/cGXP training for all maintenance staff, following corporate guidelines and policies. Develops metrics to measure department performance. Supports and promotes corporate, site vision and mission statements, and goals.
Additional Job Functions:
• Develop and implement goals, objectives and best practices
• Ability to change the thinking of or gain acceptance of others in sensitive situations.
• Ability to develop, utilize and execute project management
• Ability to multitask and manage multiple projects.
• Establish and maintain a cooperative and positive relationship with other departments
• A thorough understanding of all utility and manufacturing equipment
• Good management and practices principals
• Solid team building practices
• Develop departmental spending budgets following corporate guidelines
• Excellent written and verbal communication skills
• Proficient in computer skills and MS Office application
• Experience in maintenance trades and knowledge of building codes.
• Coordination of reports to monitor Building Management System for facility critical alarms/equipment to ensure that adequate and timely response is maintained 24/7.
• Available 24/7 to direct and coordinate emergency issues that may arise.
• Responsible for VSCRs, Deviations, SOPs in responsible area of control.
• Development of routine reports.
• Review and response to building system reports.
• Reviews design and construction documents for new site projects.

Freedom to Act
Assignments are received in task-and objective-orientated terms. Provides direction to subordinates based on general policies and management guidelines. Work is reviewed upon completion for adequacy in meeting objectives. Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies.



Supervisor Relationships
Accomplishes results through lower-level subordinate supervisors, leads or through experienced exempt/non-exempt employees who exercise significant latitude and independence in their assignments in terms of costs, methods and employees. Often heads a centralized functional activity.

Operations Involvement / Direct Work Involvement
Responsible for all projects assigned to the organizational unit. Acts as an advisor to subordinate supervisors, leads or staff members to meet schedules or resolve technical or operational problems. Directly participates in establishing and administering many centralized functional projects. Develops and administers budgets, schedules, and performance standards.

Impact
Ensures that projects/work plans are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds. . Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

Liaison
Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling.

JOB REQUIREMENTS: Typical Education:
Bachelors degree in Engineering (5 – 10 years) or Masters Degree in Engineering (2 –5 years) desired. Work history (ie Department supervisor), may be substituted for technical degree (10+yrs experience in a cGXP environment, in a supervisory role)

Typical Experience:
5 – 10 years

Certificates, Licenses, Registrations:
N/A

Technical Knowledge:
Pharmaceutical systems, industrial utilities, process equipment, GMP, GXP,
HVAC, General Construction Practices, Maintenance Software, Building Management
Systems

Computer Skills:
Outook, Internet Explorer, Capability to Utilize Various Programs Developed for Day to Day Maintenance Operations, Specialty Maintenance PM Software, MS Office Programs (Excel, Word, Projects, etc.)


Job Complexity:
Job has a high degree of technical complexity and requires in-depth understanding of systems, programming languages and interface capabilities. This position requires a meticulous attention to detail.

Supervision:
This individual will report directly to Senior Manager on the Business Analytics team, but requires a high degree of independence and initiative and ability to self-start with little direction


If you are interested in this position please click the Apply Now button below and search for Req #. 01947.

MedImmune is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.