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Durham, North Carolina, United States
Onsite
JOB SUMMARY
The Facilities Engineering Department is responsible for all aspects of maintaining the site infrastructure in an active reliable state to support cGMP operations. Facilities Engineering oversees the architectural features of the buildings, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, and Automation for the facility. A Facilities Engineer III is responsible for providing technical support for ongoing operations by serving as a system owner for Facilities’ systems, maintaining the site in a compliant state, and ensuring engineering and quality standards are maintained. Facilities Engineering is responsible for the generation and implementation of Change Controls, Corrective Actions Preventive Actions, Deviations, and other quality system records. As a part of project execution, a Facilities Engineer III will support the design, implementation, commissioning, and validation of new systems or the modification of existing systems and serve as a project manager or project engineer for multiple concurrent projects. Project Management activities may include scope definition, scope adherence, stakeholder agreement, budgeting, scheduling, risk management, procurement, and installation support. Facilities Engineering works within cross-functional teams to ensure the success of these projects. A Facilities Engineer III is expected to coordinate the activities of outside contractors and trades.
JOB RESPONSIBILITIES
Responsibility Direct technical and management aspects of multiple projects to ensue on time delivery, project compliance, budget, and required deliverables. Support the Maintenance and Facilities functions for multiple locations including corrective and preventative maintenance and repair of facilities, utilities, and equipment. Support Validation with the planning and execution of commissioning and validation protocols. Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems. Develop and maintain standard operating procedures and other procedures for installed systems.
JOB DESCRIPTION
Support and comply with engineering standards, drawing controls, project controls and other procedures and standards necessary for the successful operation of the department as well as the creation and maintenance of the same. Other assigned duties.
MINIMUM REQUIREMENTS
Bachelor of Science degree in mechanical, chemical, or electrical engineering and 5-6 years of progressively responsible facilities development, facilities construction, and maintenance activities. OR Master of Science degree in mechanical, chemical, or electrical engineering and 2-3 years of progressively responsible facilities development, facilities construction, and maintenance activities.
Preferred:
• Facilities management experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device industries).
• Knowledge of the facility operations typical to the biotechnology/pharmaceutical industry.
• Knowledge of federal, state, and local building code requirements.
Language Ability
To concisely write reports and to effectively communicate information to executive management, managers, technicians, government agencies and customers. Reasoning Ability to apply engineering principles and problem-solving skills to everyday challenges.
Math Ability
Strong math and analytical skills required. Ability to perform heat load calculations and size utility systems. Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity.
Physical Demands
Execution of assigned tasks will require the ability to access hard to reach areas of the facility to include confined spaces, cramped or low ceilings, interstitials, and mechanical rooms.
Computer Skills
Microsoft Office (Word, Excel, PowerPoint and Project), AutoCAD Equipment Use Standard hand tools, power tools, electrical multimeter, large format plotter, computer, telephone, copy and fax machines.
WORKING CONDITIONS
Are there particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, travel, work space, etc.)? Yes No If yes, please explain: 1. Incumbents may work with toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment. 2. Supports the Patriot Park Facility located at 47 National Way in Durham North Carolina 3. Non-routine off-hours weekday work may be required. Off-hours response time to system anomaly: 1 hour maximum. 4. Non-routine week-end work may be required. 5. Must comply with all applicable rules and regulations of the company and the Pharmaceutical / Biotech industry including FDA regulations such as cGMP, GDP, Health Safety Environment regulations and company regulations such as the employee handbook. Essential Physical Functions Check physical demands that apply. 1. Describe job responsibilities that require physical demands checked. Strength a. Standing 15 % of time Interfacing with staff and servicing equipment Walking 15 % of time Walk to various site locations Sitting 70 % of time Using computer, using phone, meetings b. Lifting 40 lbs. Pick-up and movement of equipment associated with field installation Carrying 20 lbs. Carrying of tools and other equipment needed for work in the plant. Pushing lbs. Pulling lbs. 2. Climbing Use of ladders for work over head or to access mechanical equipment in the plant interstitial. Balancing Essential Physical Functions 3. Stooping Movement in tight or cramp locations around mechanical equipment or in the plant interstitial. Kneeling Movement in tight or cramp locations around mechanical equipment or in the plant interstitial. Crouching Movement in tight or cramp locations around mechanical equipment or in the plant interstitial. Crawling Movement in tight or cramp locations around mechanical equipment or in the plant interstitial. Reaching Overhead work Handling. Speaking Hearing Seeing Depth Perception Color Vision NOTE 1: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.