Facilities Engineering Specialist

Overview

The Facilities Engineering Contamination Control Specialist position will be working cross functionally to support Cook Inc. Manufacturing sites with a focus on Contamination Control, Quality System documentation and being the technical liaison between Engineering, Operations and Supplier. The candidate will act as a Subject Matter Expert (SME) for the Contamination Control process.

Serve as the process owner and point of contact for the Contamination Control Program. The Contamination Control Program is the set of processes and procedures designed to mitigate and/or prevent physical, chemical, and biological contamination of product, facilities, and other activities and equipment that support the manufacture of medical device products at Cook Inc.

Work cross functionally between operations, engineering, regulatory, supplier group and the QAC Laboratory to ensure items being requested, purchased and used in manufacturing have been approved for use.

Develop and maintain controlled housekeeping procedures for the manufacturing areas. Ensure all manufacturing cleaning materials, gowning materials, and equipment are evaluated, analyzed, documented, and approved.

Ensure continued improvement on Contamination Control challenges / opportunities. Work with Supplier Engineering and Vendors to ensure support items are meeting both cost and compliance goals. Possess the ability to manage multiple complex projects with a high level of detail and accuracy.

Understand and conform to Corporate and Quality standards such as:
Quality System Regulation (QSR), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP). Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Must work and interact effectively and professionally with and for others throughout various levels of the global organization. Must strictly adhere to safety requirements. Maintain regular and punctual attendance. Must maintain company quality and quantity standards. Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision. Ability to remain calm and receptive in fast paced situations.

Associates Degree in Chemistry, Biology, Engineering or related field, or experience of such kind and amount as to provide a comparable background. Advanced understanding of cGMP, CFR 820 and ISO regulations. Proficient in Microsoft Office software (Word, Outlook, etc.).

• 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.