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SUMMARY
This leadership position reports to the Plant Manager and is responsible for managing all aspects of facilities operations at the Integra Tissue Technologies Plant located in South Boston and the build out of our new manufacturing facility in Braintree ensuring the plant is functional, efficient, and safe for production. 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 will have responsibility for supervising a staff of engineers and managers/supervisors, and hourly employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
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 plant shutdowns including 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 office facilities 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.
Oversee and direct all performance management, training, development, job descriptions, and safety procedures for all direct reports.
MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelor's degree in Chemical or Mechanical Engineering or a related technical discipline is required; a Masters degree and/or MBA is preferred.
8+ years of experience in regulated facility operations management, preferably pharmaceutical or medical device
8+ years of experience in leading a team (direct reports or projects).
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.
Experience with site transfer and/or building of a new facility preferred.
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.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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