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Facility Validation Manager

Company: Patel Consultants Corporation
Location: Princeton
Posted on: August 4, 2022

Job Description:

RIGHT-TO-HIRE OPPORTUNITY! Responsibilities

  • Manages staff, vendors and contractors responsible for maintaining all aspects of the facility, including; pest control, building maintenance, calibration, cleanroom environments, security, exterior grounds, and contract cleaning.
  • Responsible for managing the facilities and maintenance department budget to ensure maintenance, calibration, capital expenditures, and other facilities programs are funded and executed within budget variance.
  • Responsible for managing the plant equipment preventive maintenance and calibration programs to ensure all PM's are completed in timely manner and meet all regulated specifications.
  • Will be responsible for all aspects of the CMMS including scheduling, reporting, work order generation and assignment.
  • Manage and monitor preventive maintenance and calibration processes and makes adjustments to schedules as necessary.
  • Oversee and supports Building Management Systems and EMS including monitoring of and reconciliation of alarms.
  • Maintains all required Facilities and EHS training as required.
  • Adheres to all safety procedures and hazard communication.
  • Effectively oversee industry "best practices" using resources, such as ISPE and PDA and continuously upgrades the Site's processes and procedures.
  • Manage and execute deviations, investigations and CAPAs associated with facilities equipment, systems and processes.
  • Manages site compliance with current FDA regulatory requirements and expertise to work with all levels of management, staff and internal departments including outside contractors and vendors, as applicableQualifications
    • BS/MS in Engineering required, Chemical Engineering preferred
    • A minimum of 8 years of facilities management experience
    • A minimum of 6 years of experience in the pharmaceutical industry with facilities operational responsibilities
    • Strong knowledge of cGMP manufacturing processes and related codes and regulations
    • Comprehensive biopharma processes and/or utilities unit operation expertise.
    • Experience managing BMS, EMS and CMMS systems.
    • Blue Mountain RAM CMMS experience desired.
    • In-depth knowledge of validation practices and associated regulatory expectations.
    • Fully capable of delving into technical facilities engineering details, as required
    • Strong leadership and interpersonal skillsSend resumes to jerry@patelcorp.com

Keywords: Patel Consultants Corporation, Trenton , Facility Validation Manager, Executive , Princeton, New Jersey

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