Celgene Sr. Manager, GMP Facilities Metrology in Summit, New Jersey

Description

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.

SR. MANAGER, GMP FACILITIES METROLOGY

SUMMIT, NJ

Position Overview:

The GMP Facilities Senior Manager of Metrology supports the successful operation of New Jersey’s GPDO commercial and clinical manufacturing and business functions with internal customers and external service providers. The incumbent in this role, identifies issues or unmet needs and initiates projects or programs to address them. The individual is responsible for managing the GMP Facility Metrology Program and calibration technicians for GMP Facilities within New Jersey. The individual would be responsible for coordinating routine calibration and demand work orders associated with all Utility and Equipment IMTE (Inspection, Measurement, and Test Equipment) while ensuring the proper cGMP procedures are followed and good documentation is executed. The individual would be responsible for managing 24/7 response to Metrology services to maintain critical business and facility operations. The incumbent would be required to meet with our business partners to ensure their needs are being met and would be responsible for achieving KPI values. The individual would be required to be hands on when necessary and proficient in instrument and controls troubleshooting. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action according to cGMP policies and procedures. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.

Essential Functions:

Manages the Metrology Program to ensure all facility/utility IMTE and controls are in good working order to ensure optimal function and condition.

  • Manages the Measurement Assurance Program (MAP) including the IMTE selection, criticality assessment, installation, configuration, calibration and associated training.

  • Performs suitability assessments with business owners and validation groups, to understand process parameters and provide the appropriate IMTE to meet the process requirements while maintaining a standard instrument approach when possible

  • Manages the GMP Facilities Calibration program identifying gaps or process improvements and creating or revising procedures and work practices to maintain a reliable and cGMP compliant calibration program.

  • Manages all calibration procedures and Measurement Data Templates (MDTs) within Celgene’s document control system and CCMS.

  • Manages calibration staff to properly maintain and operate all GMP facility and support areas.

  • Schedules, coordinates with business owners, delegates, completes and reviews routine calibration activities and unscheduled repairs / upgrades to controls, systems and IMTE in a timely manner. Ensures operational uptime for all facility, production and laboratory equipment as it relates to controls and IMTE.

  • Provides oversight, support and direction to outside contracted calibration and controls service providers.

  • Manages all in-house standards, including the selection, purchasing and maintenance

  • Manages and performs utility/facility controller/PLC periodic reviews of configuration settings to verify the qualified state of a system.

  • Performs the necessary software revision upgrades to maintain any facility/utility system applications.

  • Initiates deviations as they relate to calibration OOT or non-conformance conditions. Provide necessary investigations to support root cause analysis. Manages any IMTE or calibration program CAPAs related to deviations

  • Manages contracts, POs and invoices to support OEM calibrations, outsourced calibration staff, equipment, instruments, standards and parts.

  • Manages BMS/BEMS (Building (Environmental) Management Systems) service contracts and control techs.

  • Delegates and performs daily system inspections on the BMS (Building Management Systems) and BEMS (Building Environmental Management Systems) to dispatch the appropriate response to address any control issues.

  • Generates and manages BEMS response plans associated with instrument alarms with Business Owners.

  • Manages 24/7 response to critical equipment and utilities alarms

  • Review and approve qualification and commissioning documents as they relate to the calibrations of equipment and systems associated with GMP Facilities, production and laboratory equipment, including URS(s), IQs, OQs and Validation Plans.

Initiates, manages and leads projects of moderate scope and complexity within their functional area.

  • Addresses calibration or IMTE 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 calibration schedules to improve reliability, and optimize labor utilization, cost savings and safety enhancements

  • Serves as a Facilities Calibration site representative during interactions with all cross functional groups, as required.

  • Provides IMTE and Calibration coordination with the Project Engineering team for capital projects. Includes the defining and generation of calibration procedures in preparation for Installation Qualifications.

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.

  • Initiate the necessary change controls and impact assessments to manage the replacement of instruments associated with GMP equipment.

  • 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 calibration work orders including administering and monitoring planned and unplanned work order activity

  • 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 Instrumentation 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 calibration procedures, work instructions and guidance documents

  • Drives Metrology 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 instrument 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 instrument/controls-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

  • 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 control systems including PLCs, HMIs, Building Automation Systems, CCMS (Computerized Calibration Management Systems).

  • Broad working knowledge of critical utility systems such as compressed gas, USP water systems, vacuum, chillers, waste, as well as security, network infrastructure and fire alarm systems

  • Demonstrated ability to utilize specialized testing equipment such as instrument standards, Fluke multi-meters for troubleshooting and initial triage.

  • Direct knowledge and experience with the operation and troubleshooting of controllers for 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 when necessary

  • 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, Visio, Project and Outlook, and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.

  • Familiarity and experience with systems such as BMRAM (Blue Mountain Regulatory Asset Management), Siemens & Honeywell BAS is beneficial.

Competencies:

  • Technical Knowledge

  • Problem Solving / Troubleshooting

  • Team Player

  • Multi-tasking

  • Customer Focus

  • Action Oriented / Tenacity

Education & Experience:

  • BS degree in electrical, mechanical or relevant engineering discipline.

  • Minimum 10 years of Facilities Calibration experience supporting and troubleshooting

  • Minimum 5 years of GMP Facility services

Working Conditions:

Physical / Mental Demands:

  • Work required in and around laboratory and regulated environments, including clean rooms.

  • 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 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.

Environmental Conditions:

  • 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

#LI-POST

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.