CMMS System Administrator, Facilities - GenScript/ProBio

Job Scope: 

The Systems Administrator, Facilities will work with the Director of Facilities Operations, Technical Services, the integrated facility management group, Quality Management and Manufacturing Management on the management and daily operation of the CMMS system at the Hopewell site. The role will involve asset management planning for calibration and maintenance activities, working with other project related cross function teams and coordinating activities with all agency technical support teams. Incumbent will ensure regulatory compliance of all inspection requirements; play a major role in end-user support, ongoing development, and support of the CMMS system. The incumbent must adhere to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Essential responsibilities:

• Manage CMMS System administration and configuration modules, workflow, development and user administration.
• Serve as primary contact for CMMS System Users and IT support.
• Investigates and troubleshoots issues and escalates to IT Help Desk as needed
• Configures/adds new users and services as necessary.
• Maintains system operational, configuration, or other procedures.
• Performs periodic performance reporting to support compliance metrics and capacity planning.
• Support and maintain CMMS system reports; run queries and create ad hoc reports.
• Support all CMMS environments, including testing, development, pre-prod, training and production
• Enter data into CMMS to support work order management and calibration data.
• Participates in and, as necessary, actively contributes to, investigator meetings.
• Process all GxP and non-Gxp lab instrument asset status updates (new, retirement, moves, owner changes, computer upgrades, etc.).
• Support internal audits by providing requested system information - through either the CMMS Application (reports, screenshots) or by writing on-demand SQL queries.
• Provide extracts / documentation to support QA approved Change Controls / Quality Events.
• Create formal work instruction that documented the standards for managing instruments within the CMMS (i.e. instrument naming conventions, parent / child hierarchical relationships, system owner identification, etc.).
• Determine the appropriate service interval (frequency) and provider (internal vs. vendor) with owner's assistance.

Qualifications:

• A Bachelor's degree in Computer Science or related field, and a minimum of 4 years' experience in system administration, business system analysis, escalation support or systems administration experience or 10 years of working experience with IBM Maximo Life Sciences Software or equivalent in a pharmaceutical, biotechnology or related environment.
• Knowledge of cGMP, GXP, Good Automated Manufacturing Practice (GAMP), Software Development Life
• Cycle (SDLC) regulations, knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Proficiency with Computerized Maintenance Management Systems (CMMS).
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

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