CMMS Facility Engineer

Genscript Biotech • Pennington, NJ

79d • $80,000 - $110,000

About The Position

CMMS Specialist, Facilities will work with the Sr. Manager of Engineering, the integrated facility management group, Quality Management and Manufacturing Management on the management and daily operation of the Computerized Maintenance Management Systems (CMMS) 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.

Requirements

• Bachelor's degree in Computer Science or related field.
• Minimum of 4 years' experience in system administration, business system analysis, escalation support or systems administration experience.
• Working experience with IBM Maximo Life Sciences Software or equivalent CMMS in a pharmaceutical, biotechnology or related environment.
• Knowledge of cGMP, GXP, Good Automated Manufacturing Practice (GAMP), Software Development Life.
• Asset Lifecycle knowledge for pharmaceutical, manufacturing and laboratory systems and equipment.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment.
• Analytical thinker with excellent problem-solving skills.
• Excellent planning, organization and time management skills.

Nice To Haves

• Degree in Mechanical, Chemical, BioMolecular Engineering or equivalent.

Responsibilities

• Manage CMMS System and configuration modules, workflow, development and user administration.
• 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.
• New data entries into CMMS to support work order management and calibration data.
• Configures/adds new users and services as necessary.
• New asset and location creation.
• Job Plan Creation.
• PM creation.
• Data sheets.
• Participates in and, as necessary, actively contributes to, investigator meetings.
• Process all GxP and non-Gxp lab instrument asset status updates.
• Support internal audits by providing requested system information.
• Provide extracts/documentation to support QA approved Change Controls/Quality Events.
• Create and revise formal work instruction that documented the standards for managing instruments within the CMMS.
• Determine the appropriate service interval (frequency) and provider (internal vs. vendor) with owner's assistance.
• Review Equipment and System Drawings, Specifications, and Submittals.
• Review Change controls and IQOQ/PQ for new equipment onboarding and decommissioning.
• Troubleshoot, determine root cause of problems and provide optimization strategies for utility systems and equipment.
• Provide spare parts and reliability analyses for critical components, equipment, and systems.

Benefits

• Equal opportunity/affirmative action employer.
• Drug-free workplace.

What This Job Offers

• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees