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

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 :

Last updated : 2024-06-06