Celgene Manager, Warren Facilities in Warren, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Manager, Warren FacilityWarren, NJ
This Facility Manager position exclusively supports the successful operation of the Warren Cell Therapy Development and Clinical Manufacturing Facility. The primary responsibility of this role is to ensure business continuity of the development and clinical supply operations of the Warren Facility, allowing the Production and Quality staff to serve the urgent needs of our waiting patients.
To do this, the incumbent identifies issues or unmet needs and initiates projects or programs to address them. The individual is responsible for managing facility technicians including HVAC, Electrical, Plumbing, General Maintenance, Calibration, Janitorial and Controls for GMP Facilities. The individual would be responsible for coordinating preventative and demand work orders with the respective trades while ensuring the proper cGMP procedures are followed and good documentation is executed. The individual would be responsible for 24/7 response to facility services to maintain critical business and facility operations. The individual would be required to be hands on when necessary and proficient in utility maintenance and troubleshooting. Using solid analytical skills, the incumbent should be able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action according to cGMP policies and procedures.
Maintains all facility systems, equipment and assets in good working order to ensure optimal function and condition.
Supervises facility staff to properly maintain and operate all GMP facility and support areas. Facility staff includes HVAC Technicians, Electricians, Mechanics, General Maintenance, Calibrations Technicians, Controls Technicians and Janitorial services.
Coordinates, delegates, completes and reviews scheduled preventive maintenance activities and unscheduled repairs / upgrades to office, laboratory and manufacturing facilities and systems in a timely manner. Ensures operational uptime for all facility infrastructure, fixtures, equipment and systems.
Performs and coordinates variety of service, maintenance and repair work to support the successful operation and continual upkeep of the GMP facility and support areas, including minor construction, painting, event set up, minor office reconfigurations, and equipment assembly / installations.
Works closely with the Cell Therapy Development (CTD) office staff and leadership to understand and execute the needs of CTD for office and lab space, large meeting room configuration, and Warren site events.
Delegates and reviews daily rounds of building, grounds and equipment per work instructions. Identifies health and safety hazards, maintenance and repair issues, and takes appropriate action to remedy findings including prompt notification to management
Provides 24/7 response to critical equipment and utilities alarms
Provides oversight, support and direction to outside contracted service providers.
Initiates, manages and leads projects of moderate scope and complexity within their functional area.
Addresses maintenance or repair issues, determines scope of work, material and equipment needed, anticipates next steps, and coordinates with impacted groups
Recommends and implements changes to critical / ancillary systems, processes, and maintenance schedules to improve reliability, and optimize labor utilization, cost savings and safety enhancements
Serves as a Facilities site representative during interactions with all cross functional groups, as required.
Provides facility coordination with the Project Engineering team for capital projects
Provides quality assurance and regulatory oversite
Be proficient in cGMP guidelines in accordance with company policy and procedures. Provide direct oversite of technicians and external vendors to ensure compliance.
Complete and review documentation associated with preventive, corrective and service work orders to ensure cGMP good documentation practices and change control procedures are being followed
Report any facility deviations to support NOEs and quality investigations. Provide SME knowledge to support investigations and CAPAs.
Provides oversight of GMP training curriculum for internal technicians and external vendors.
Coordinate maintenance activities with operational leads to ensure compliance with preventative maintenance and calibration schedules
Performs business process and administrative tasks including scope of work, cost assessment, and documentation.
Manages scheduling and coordination of PM work orders including administering and monitoring planned and unplanned work order activity as well as conference room setup, as required
Completes and reviews documentation associated with preventive, corrective and service work orders to ensure good asset history and department metrics are maintained
Provides oversight of Facilities service contracts to help ensure proper agreements are established, concise scopes of work are developed, and detailed schedules with service / labor costs are submitted
Provides oversight of EHS, Facility and Operational training curriculum for internal technicians and external vendors.
Provides guidance and review in the development and revision of required preventive maintenance procedures, work instructions and guidance documents
Drives Facilities operating budget within target goals for all contracted services and expenses
Drives the identification, procurement and inventory control of spare parts, materials and supplies as required to ensure availability for maintained equipment.
Establishes a PdM (Predictive Maintenance) program based on equipment failure rates and life cycle analysis.
Promotes and provides excellent customer service and support.
Regularly reviews, prioritizes, coordinates and promptly responds to work orders and service requests.
Provides technical support and guidance on facilities-related issues. Interfaces with customers to ensure all expectations are being met
Maintains a positive relationship with all the members of the Facilities department and our site customers while promoting a positive team environment
Promotes and maintains compliance with corporate, safety, security and regulatory policies.
Maintains all assigned Corporate, Facilities, GMP and EHS training as required
Provides administrative support with site security access and control
Provides administrative support and site coordination with facility fire alarm and fire suppression systems
Adheres to all safety procedures and hazard communication; updates and maintains applicable safety data sheets
Ensures work areas in a clean, safe and organized state including all work rooms and storage areas.
Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
Strong understanding of building systems including life-safety, lighting, mechanical, electrical, and plumbing
Strong knowledge of critical utility systems such as compressed gas, vacuum, waste, as well as security and key managements systems and policies
Broad working knowledge of facility management systems such as CMMS (Computerized Maintenance Management Systems), BMS (Building Management Systems), BEMS (Building Environmental Monitoring System), Security access control /camera systems, PLC (ladder logic)
Demonstrated ability to utilize shop hand tools, power equipment, and specialized testing equipment
Direct knowledge and experience with the operation and troubleshooting of incubators, refrigerators, freezers, cold rooms, environmental chambers, glassware washers and various lab equipment
Strong experience in coordinating outside contractors in support of facility operations and maintenance, including system and equipment repair, upgrade, installation, start-up and commissioning
Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Ability to work “On Call”, overtime, off schedule and weekend hours to provide site operational support
Strong written and verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Ability to follow oral and written instructions, read, interpret and update engineering manuals/drawings relevant to the trade or the assigned task, and easily comprehend work orders.
Firm working knowledge of building codes, NEC, NFPA, OSHA and other basic safety training
Understanding of ergonomic effects
Understanding of ISPE, ISO and CFR guidelines for the pharmaceutical industry as they apply to development, clinical and commercial manufacturing
Familiarity with FDA / cGXP environments and associated compliance regulations
Adept in Microsoft Office Suite – Word, Excel and Outlook, and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.
Problem Solving / Troubleshooting
Action Oriented / Tenacity
Education & Experience:
AA / AS degree or acceptable trade certification of experience in combination of education and practical experience
Minimum 15 years of Facilities / Operations experience supporting and troubleshooting
Minimum 5 years of GMP Facility services
Physical / Mental Demands:
Work required in and around laboratory and regulated environments.
Working in and around chemicals and potent compounds.
Working in and around confined spaces.
Ability to lift greater than 50 lbs.
Ability to perform on elevated work platforms.
This position requires regular medical surveillance and will require incumbent to wear a respirator or gown.
Ability to work a minimum of a 40 hours work week.
Ability to work Rotating Shift as needed as well as Emergency, Overtime, and weekend shifts.
Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
Ability to work safely in an environment with exposure to high temperatures / pressure steam, compressed gasses, various noise levels, and high voltage energy supplies.
Ability to sit, stand and move within workspace for extended periods.
Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 50lbs
Ability to sit, stand, walk and move within workspace for extended periods
Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling
Ability to climb ladders and work in elevated areas.
Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies
Environment may include working at heights, in cold temperatures, and/or constricted spaces
Ability to work safely when working alone, or working with others.
Ability to work within a GMP environment and properly gown according to room classifications and procedures
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.