Facilities & Maintenance Manager, Clinical Supply - New Brunswick, United States - Bristol-Myers Squibb

Bristol-Myers Squibb

Verified Company

New Brunswick, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.

Take your career farther than you thought possible.

Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide.

In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow.

As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.

Job Title:
CSO Facilities & Maintenance Manager

Location:
New Brunswick, NJ

Position Summary:

To provide leadership, technical expertise and troubleshooting ability on all aspects of calibration support, maintenance support and mechanical system operations within the New Brunswick, NJ R&D Manufacturing Clinical Supply Operations.

Additionally, will provide input in the development & execution strategy of Preventative Maintenance (PM) & Predictive Maintenance (PDM) practices to ensure compliance (GMP and PSM) with company policies and appropriate regulatory standards.

Also provide support for the development and execution of various safety programs and directives to ensure compliance with the BMS safety standards.

Role &
Responsibilities:

Responsible for defining weekly maintenance/ mechanical/ systems/ instrumentation technician staffing strategy; oversight for scheduling of maintenance activities, process setup support and maintenance/capital work across the NBR Clinical Supply Manufacturing areas.
Responsible for reviewing, understanding, approving, prioritizing, and ensuring access is granted for all work in scope of the IFM vendor.
Responsible for oversight of IFM Hard Service outcomes; reviews CPI/KPI/GPI where applicable.
Responsible for the ontime execution of calibrations and PM's within the CSO areas and API-OPs Scale-Up Facilities. This will require an interpretation and understanding of process flow diagrams (PFDs).
Develops and/or approves SOPs and other technical documentation required for maintenance and mechanical system operations.
Interfaces with the Storeroom to ensure proper materials and parts are identified and available to sustain planned & preventative maintenance, and corrective activities.
Manages their respective maintenance team with responsibility over all asset/equipment modifications, PMs and Job Plans Master Data through the Bulk Loader within the CMMS system.
Manages and maintains the optimization of preventative maintenance frequencies through Mechanical Integrity programs.
Ensures all maintenance activities and work order processing are performed in accordance with established guidelines, operating procedures and cGMP directions to ensure consistency & completeness.
Ensures the proper execution and compliance of maintenance work orders within the CMMS system.
Assists in the creation, tracking and completion of maintenance related Quality Events, investigations, CAPAs, and Out of Tolerance (OOT) situations.
Conducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems.
Acts as a backup to other NBR R&D Manufacturing Maintenance Managers in times of need, i

e:
illness, vacation, etc.

Support implementation and management of the safety compliance standards; support investigations/Near Miss program and Corrective Measure implementation across the NBR R&D Manufacturing facilities.
Adhere to safe work practices, energy control procedures and lockout/tagout programs across the NBR R&D Manufacturing facilities.
Management of the change control program across the NBR R&D Manufacturing facilities. Serve as an area reviewer and approver of change controls.
Partner with stakeholders and be responsible for defining user requirements for new mechanical systems.
Responsible for working with the broader CSO Functional Area groups within the NBR R&D Manufacturing space to provide startup, commissioning, and qualification/validation support of mechanical systems including onthefloor troubleshooting of equipment.
Provide technical expertise in the design and support of various safety programs to ensure departmental compliance.
Provide technical expertise in the design and support