Description/Comment:

Position Summary
Supports and coordinates all administration functions within the Facilities group to ensure that equipment is enrolled, maintained, and calibrated properly on schedule and per SOP's. Assists with coordination and planning of corrective work orders and preventative maintenance activities. Additionally, creates and revises Standard Operating Procedures (SOPs).
Essential Functions
Responsible for operation of the Regulatory Asset Management Program, including the following:
• Generate monthly preventive maintenance and calibration schedules
• prepare all documentation and ensure completion of follow-up activities including documentation updates, creation of electronic records, approvals, close-out, activity re-scheduling, customer notification and archiving
• Manage maintenance work orders, including work order generation and ensuring all follow-up activities are complete, including complete documentation, approvals, close-out, and customer notification and archiving
• Maintain parts inventory
• Document the use of spare parts in all preventive maintenance and corrective maintenance work orders
• Maintain asset database, including equipment enrolments, status changes, PM, and calibration program updates
• Generate and distribute system reports
• Maintain controlled departmental records
• Schedule and coordinate preventive maintenance work with contractors and customers
• Facilitate SOP training to contractors. Ensure training is current with latest SOP revision
• Create Building Maintenance System monthly trending graphs on all GMP equipment and reconcile GMP alarms daily
• Assist in writing and revising facility SOP's and appropriate procedures to ensure high reliability of department documentation and procedures
• Provide administrative support to Facilities maintenance department during shutdowns and other major planned work activities
• Perform other duties and responsibilities as assigned by Facilities Director
• Perform other duties as assigned
• All employees are responsible for the general upkeep of work and shared spaces
• Punctual and regular attendance is required of all employees

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the position.

Supervisory Responsibility
N/A

Travel
N/A

Qualifications
Experience:
• 3+ years' experience

Education
• High School Diploma or equivalent required or Associates Degree

Skills & Knowledge
• Must possess intermediate PC skills specifically Word, Excel
• Strong decision-making ability, capable of setting and balancing priorities
• Experience managing teams and complex projects
• Experienced in Equipment/System Validation/Qualification Activities
• Experienced in Life Cycle Deliverables
• Experienced in writing protocols and SOPs, involvement in Change Control and CAPA activities

Abilities

• Ability to problem solve and troubleshoot systems in a manufacturing environment
• Ability to interact cross-functionality across the organization
• Ability to be proactive and build strong partnerships
• Ability to multi-task while maintaining routine on-going activities

Working Conditions
This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.

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