Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Maintenance System Planner & Scheduler

Responsible for operating the Computerized Maintenance Management System (CMMS), working with other departments, vendors and contractors to maintain and improve the system; Become expert on the CMMS and drive its use for optimized output and service throughout all areas of the site. Compiling and distributing maintenance reports and for training users in the operation of the system. Additional responsibilities include recognizing the need for and writing maintenance procedures.

Develop and implement World Class planning process into all Maintenance functions. Perform all functions required to maintain and sustain the program that would include: identifying individual job scopes; planning & scheduling individual maintenance jobs; coordinating multiple crafts/disciplines to avoid interference and downtime; optimize manning requirements for each job; coordinating proper inventory & non-inventory materials; and job follow-up for KPI reporting and continuous improvement action.

Coordinate and manage required Maintenance contractors and suppliers. Reduce emergency and recurrent work by efficiently/effectively executing unplanned emergency work that will result in minimal disruption of normal Maintenance requirements.

Major Accountabilities

• Operate and oversee the Maintenance Management System (CMMS).
• Establish, maintain and improve the Maintenance Planning and Scheduling business flow process.
• Accurately estimate time required to complete maintenance work along with manpower requirements.
• Develop and maintain Query programs to aid associates in obtaining information from the CMMS.
• Create and maintain maintenance strategies/tactics regarding the Site objectives.
• Assign calibration and maintenance schedule to equipment.
• Developed and maintain the computerized Equipment Manuals System.
• Periodically meet with other departments, reviewing their needs/requests and coordinate changes as needed.
• Optimize Preventative Maintenance program and coordinate with Autonomous Maintenance team the im- provements.
• Conduct regular field audits to observe the execution and discuss the quality of the plans with the mechanics and Maintenance Supervisors.
• Have a good understanding of what the KPIs mean and how they are calculated.
• Conduct regular reviews of all Critical Spares in area of responsibility.
• Advise the Planned Maintenance department when a Root Cause Failure Analysis might be necessary.
• Developed monthly reports pertain to all charges to be generated against cost centers for labor, parts, sup- plies and materials.
• Perform the training required for associates to use the CMMS;
• Write maintenance procedures as required.
• Work with Information Technologies (IT) to ensure software upgrades are installed in a timely manner.
• Troubleshoot all new software changes to the CMMS.
• Perform other duties as may be required or necessary.
• Know, understand, and follow all applicable health, safety & environmental policies and procedures.
• Promote a strong safety culture by modeling safe behaviors and holding self and others accountable for working safely.

• Solid appreciation of quality management methods and practices related to plant and equipment reliability. Manual / Mechanical Skills:

• Ability to work with computer software for inventory and maintenance system, reports, letters and inter-departmental correspondence.
• Mechanical skills to comprehend functioning of equipment in order to be able to order and supply proper parts and keep an adequate maintenance of equipment.
• Ability to maintain an accurate filing and retrieval system.
• Most duties are accomplished according to general directions established by the supervisor; however, in- cumbent must be analytical to solve problems with the system, locate errors and contact appropriate person- nel to correct them. Must be able to follow set standards for entering and tracking information in the system. Must analyze information to alert user departments of overdue procedures. Must be creative and innovative to find new or better ways to use the system.
• The employee must occasionally lift and/ or move 50 lbs. Specific vision abilities required by this job includes close vision, depth perception, and the ability to adjust focus. While performing the duties of this job, the employee occasionally works near moving mechanical parts or equipment in function to determine appropri- ate maintenance required or to verify the completion of work orders. In addition, Incumbent works in an office area located in the maintenance shop. There is occasional exposure to noises of equipment. Travel and overnight absence from home will be approximately 5% of the time.

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.