Overview

The Facilities/Maintenance Specialist I is responsible for Controlled Manufacturing Area (CMA) environmental monitoring systems, alarm investigations and documentation. This position is involved with complex systems and software, identifies areas of improvement, may manage projects from design requirements to implementation, including defining scope and objectives. This position defines and creates technical specifications for a wide variety of projects.

Responsibilities

• Ensure equipment being moved into CMA is properly setup in Maintenance and Calibration systems- Monitor CMA environmental monitoring system; alarm investigation and documentation- Ability to read and comprehend blueprints, specifications and sketches and develop/modify CAD drawing for facility or systems- Write and modify facility/system documents and procedures.- Participate in planning, documenting, commissioning, and start-up of new and modified facilities and system installs/upgrades.- Translate project plans into coherent, credible, realistic project schedules.- Possess the ability to manage multiple complex projects with a high level of detail and accuracy.- Understand complex systems and be able to identify potential areas of improvement.- Define and create technical specifications for a wide variety of projects.- Ability to work hands on with critical equipment/systems.- PLC interface and configuration/trouble shooting of such equipment.-Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Qualifications

• Must have an AS in engineering and/or electronics or related field; or experience of such kind and amount as to provide a comparable background.- Good understanding of GMP preferred.- Proficient in or good working knowledge of AutoCAD preferred.- Proficient in Microsoft Office software (Word, Outlook, etc.)- Minimum of 5 years Facility/Maintenance or engineering experience.with computers, etc.

Physical Requirements:

• Ability to travel approximately 20% as necessary to other facilities.- Must be able to perform reasonable job functions requiring periods of standing, walking, climbing, balancing, lifting up to 50lbs, as well as those requiring manual dexterity, effective listening and communication.- Occasionally required to sit.- Occasionally lifts and/or moves more than 100 pounds.- Requires close vision, distance vision, color vision and depth perception.

Requisition ID2024-14032

Posting Date2 months ago(3/5/2024 8:40 AM)

Job Location(s) Ellettsville IN United States

Travel Less than 10%

Position Type Full Time

Company Cook Inc - Ellettsville

Category Facilities/Maintenance