Director Facilities Engineering
Responsibilities SUMMARY DESCRIPTION This position reports to the CMC Plant Manager and is responsible for managing all aspects of facilities operations at the Integra CMC Plant located in Plainsboro NJ. This includes overseeing all mechanical, electrical, automation and utility engineering support, driving business strategies, acting as primary contact for all building/facility management, and executing site business continuity projects. This position manages the Facility Engineering staff, Facility Maintenance staff, Calibration staff, and Stationary Engineers that work to maintain and calibrate all CMC facility equipment and production equipment. This position will have responsibility for supervising a staff of engineers and managers/supervisors, and hourly employees. Support production activities by ensuring fully functioning, calibrated equipment and facility resources are available for daily production in a regulated environment. Manage and implement business strategies that effectively utilize the plant's resources to achieve its mission in the areas of Facility Mechanical, Electrical, Environmental, Automation, Utility Engineering and Facilities Maintenance. Act as the primary owner interface with building landlords and their site management. Function as the primary liaison with Building and Fire departments, utilities and insurance representatives, and other inspectors. Responsible for all CMC plant shutdowns to include preventative maintenance, major projects, and plant modifications. Manage, maintain, and develop key vendor relationships to support facility operations and maintenance. Develop policies and procedures for the Facility Engineering and Maintenance organizations and the communication of these to subordinates to ensure their compliance, utilizing proper tools and safety procedures. Established budget and accurate spending projections, manage within capital and operating resources and able to identify significant capital spend requirements during budget preparation. Set departmental objectives and goals in accordance with the plant priorities. Develop/Maintain relevant departmental metrics and report progress and plans to Operations Leadership Team. Responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, ISO 13485 and ISO 9001standards, OSHA and the EPA. Manage overall CMC office facilities in B105 and B109 (approx. 75,000 sq. ft.) to ensure that facilities are safe and clean for employees. Manage contracts for janitorial, security and facility equipment maintenance and support services. Manage building emergencies such as plumbing, electrical, air conditioning, building health and environmental issues. Conduct performance reviews and other HR procedures and duties for departmental staff in accordance with company policy, i.e. submission of compensation (base salary, bonus, merit increase, promotions) for review and approval. Oversee and direct all performance management, training, development, job descriptions, and safety procedures for all direct reports. What are we looking for? Qualifications BS in Chemical or Mechanical Engineering, MS and/or MBA preferred. 10
years of experience in pharmaceutical or medical device facility operations management 10
years of experience in managing engineering staff and activities. Experience in new GMP site startup, GMP commissioning and GMP validation. Comprehensive understanding and experience in startup, shutdown, operation and maintenance of ISO 5, ISO7 and ISO 8 Clean Rooms Facilities. Management of facilities equipment repair/preventive maintenance programs. Relevant experience in working with local/regional architects, designers, MEP engineers, structural, specialty professional engineers Proven success in managing and delivering cross-functional tasks with effective liaison between EH&S, IT, Security and Procurement, including external contractors, vendors, professional consultants, and Fire/Building/Planning/governmental agencies Proficient in Root Cause Analysis (RCA) and Failure Modes and Effects Analysis (FMEA). Knowledge of GMPs, FDA guidelines, purchasing practices and process validation. Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience Strong written, verbal, and interpersonal skills Requires an in-depth knowledge of maintenance and calibration management systems Exceptional practical problem-solving skills, and communication skills Ability to multi-task, prioritize and work in a fast paced and fluid environment.
Salary Range:
$150K -- $200K
Minimum Qualification
Plant & Facilities ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
years of experience in pharmaceutical or medical device facility operations management 10
years of experience in managing engineering staff and activities. Experience in new GMP site startup, GMP commissioning and GMP validation. Comprehensive understanding and experience in startup, shutdown, operation and maintenance of ISO 5, ISO7 and ISO 8 Clean Rooms Facilities. Management of facilities equipment repair/preventive maintenance programs. Relevant experience in working with local/regional architects, designers, MEP engineers, structural, specialty professional engineers Proven success in managing and delivering cross-functional tasks with effective liaison between EH&S, IT, Security and Procurement, including external contractors, vendors, professional consultants, and Fire/Building/Planning/governmental agencies Proficient in Root Cause Analysis (RCA) and Failure Modes and Effects Analysis (FMEA). Knowledge of GMPs, FDA guidelines, purchasing practices and process validation. Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience Strong written, verbal, and interpersonal skills Requires an in-depth knowledge of maintenance and calibration management systems Exceptional practical problem-solving skills, and communication skills Ability to multi-task, prioritize and work in a fast paced and fluid environment.
Salary Range:
$150K -- $200K
Minimum Qualification
Plant & Facilities ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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