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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