Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body’s own regenerative power to improve the quality of patients lives.

Position Summary:

Responsible for supervising the Facilities functions of the Aesculap Biologics’ Facility to ensure timely and effective maintenance of the facility, facility equipment and systems . Main responsibilities are as follows:Maintenance of the facility in a state of good repair and in compliance with the cGMP. Planning, assigning, and directing the work of Maintenance Supervisors, Team Leaders, and craft persons in their designated areas. Supervising and planning of all facility related maintenance, repairs, equipment upgrades, cleaning, and projects performed over multiple shifts. Planning and executing of cost savings and expansion projects.

Responsibilities: Essential Duties

• Supervises all personnel in the facilities maintenance unit to assure proper application of company policies and procedures and to assure acceptable performance of job functions.
• Develops and oversees the preventative and predictive maintenance programs for the facilities equipment, systems and areas. Reviews the maintenance programs and implements changes for improving the effectiveness and cGMP compliance of the maintenance department and its personnel. Administers the Pest Control Program.
• Monitors Aesculap Biologics’ cleanroom functions each work day for pressure differentials, relative humidity and temperature using   the BMS and field mounted instruments to assure that proper working conditions are being maintained within the cleanrooms and their adjoining areas.
• Coordinates facility shutdowns required for performing preventive maintenance on equipment, project work and general facility modifications.
• Maintains the facilities’ systems in good working condition to include the backup electrical, chilled water, compressed air and HVAC systems to insure that that no unscheduled interruptions in the delivery of critical utilities occur.
• Develops and manages the spare parts program for all facility support equipment. Makes changes as required to reduce costs and improve effectiveness of the program using the Aesculap Biologics’ Change Management System as necessary.
• Monitors and modifies Maintenance Procedures and processes as required to assure compliance with Aesculap and Aesculap Biologics procedures and GMP regulations.
• Reviews the REES Cleanroom Monitoring System each working day to assure room conditions. Reports relevant deviations and participates in investigations and CAPA resolution in conjunction with the Manufacturing and Quality Department Managers.
• Reviews monthly maintenance expenses and prepares monthly maintenance cost forecasts. Assists with the preparation of the annual expense budget for facilities maintenance and spare parts.
• Participates in the review and approval of facilities maintenance projects and ensures the availability of resources and the utilities to assure timely completion of the required work activities.
• Retains, interfaces and oversees vendors and contractors for equipment and maintenance service purchases. Reviews technical data on equipment to be purchased to assure that it properly meets the requirements of the application which it will be performing
• Ensures that all mechanical areas and facility equipment are maintained in good working condition and that the facility is in a state of good repair as necessary for GMP compliance.
• Works in conjunction with the Quality Assurance Department and Manufacturing and in compliance with the cGMP/GTP to insure product safety.
• Interacts with local fire and building inspectors as necessary.
• Serves as the Facilities systems Subject Matter Expert during inspections by federal and state health authorities and other third party auditors.
• Serves as liaison with MRA Group (building owner).
• Arranges for and trains back up staff to service the facility to GMP compliance in the Facilities’ Manager’s planned or unplanned absence.
• This position has a direct impact on product and patient safety.
• Must comply with applicable ISO and FDA regulations as stated in Quality Manual
• Must embody the Company’s Vision, Mission and Values
• Other duties may be assigned

Expertise: Knowledge & Skills

Secondary or peripheral job functions:

• N/A

Supervisory Responsibilities:

• N/A

 

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case.  The range provided is a reasonable estimate.

$92,830-$116,030

Expertise: Qualifications-Experience/Training/Education/Etc

Required:

• Bachelor’s degree in science or engineering and 10+ years of related experience in biotech, pharmaceutical or medical device cleanroom design and maintenance; or equivalent combination of education and experience.
• Must have strong organizational and communication skills.
• Must be detail oriented.
• Computer skills in spreadsheets, word processing and databases desired
• Should have knowledge of the maintenance and operation of standard HVAC equipment and systems.
• Should have knowledge of the operation and maintenance of air compressors and their associated auxiliary equipment.
• Should have knowledge of the operation and maintenance of pumps and their associated equipment.
• Must be able to read, comprehend and apply information in equipment technical bulletins and maintenance manuals.
• Should have knowledge of distributed and local control systems commonly associated with building support systems and equipment.
• Must be able to read and understand facility drawings to include layout, electrical and mechanical.
• Must comply with applicable OSHA and local safety codes.
• Language and mathematical skills; reasoning ability:
• Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.  
• Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
• Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Desired:

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 100 pounds.

 

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Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

• The employee must occasionally lift and/or move up to 50+ pounds.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

• This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. The noise level in the work environment is usually moderate.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
 
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Equal Opportunity Employer Veterans/Disabled