Job Description
Job Summary: This role is responsible for the administration, coordination and completion of tasks on our computerized maintenance management system (CMMS).
This role requires a strong focus on maintaining the required c GMP state of the computerised maintenance management system for the Raheen Facility through strict adherence to Standard Operating Procedures (SOPs) and c GMP's.
A typical day might include:
- Administrating and coordinating activities for Blue Mountain Regulatory Asset Manager (BMRAM), the on site Computerized Maintenance Management (CMMS) System
- Coordinating the creation of equipment, system/subsystem and location hierarchies in BMRAM
- Creating assets (Equipment Code Numbers), schedules and work events for all systems and equipment
- Preparing and maintaining maintenance plan/schedule records
- Assisting users of BMRAM to navigate through the database system or troubleshoot problems encountered
- Raising change controls, creating and updating new and effective documentation to support BMRAM operations via workflows on qualified documentation systems
- Provisioning of project support to technical groups that require BMRAM input
- Maintaining the integrity of information within the CMMS system
- Supporting change controls and executing test plans for changes to BMRAM qualified systems
- Completing corrective and preventative actions (CAPA) associated with BMRAM and asset management in a timely manner
- Providing guidance and support to colleagues relating to initiation and closure of change control, workflows, CAPAs etc
- Identifying and implementing changes and improvements to BMRAM operation and maintenance activities on BMRAM
- Ensuring that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs)
- Following current good manufacturing practices (c GMPs) and good business practices
This role requires:
- A strong focus on safety and quality in all aspects of work
- Ability to work collaboratively with a team and manage responsibilities independently
- Good written, verbal and interpersonal communication skills
- Strong analytical and organizational skills
- A BS/BA in Engineering, Life Sciences or related field with 2+ years of related experience within a regulated environment preferred or equivalent combination of education and experience
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.