Facilities Engineering Specialist

Cook Medical; Bloomington (IN); On-site; USD 60,000 - 75,000; Full time

Job summary

Cook Medical is seeking a Facilities Engineering Specialist to oversee and enhance the Contamination Control Program. This role will involve cross-functional collaboration in maintaining compliance with quality standards and regulations to ensure product integrity at manufacturing sites.

The ideal candidate will have an Associate’s Degree in a related field and a strong understanding of regulatory requirements. Key responsibilities include managing procedures that mitigate contamination risks and ensuring effective communication across teams.

Qualifications

• Experience in Engineering or related field.
• Proficient understanding of regulatory requirements.
• Ability to manage complex projects.

Responsibilities

• Serve as the process owner for the Contamination Control Program.
• Develop and maintain controlled housekeeping procedures.
• Ensure compliance with corporate and quality standards.

Skills

cGMP understanding

Effective communication skills

Proficient in Microsoft Office

Education

Associate’s Degree in Chemistry, Biology, Engineering or related field

Job description

Facilities Engineering Specialist

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.

Responsibilities

• Serve as the process owner and point of contact for the Contamination Control Program.
• Define and maintain the Contamination Control Program processes and procedures designed to mitigate and/or prevent physical, chemical, and biological contamination of product, facilities, and other activities and equipment that support manufacture of medical device products.
• 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), and adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Maintain company quality and quantity standards.
• Have effective communication skills and ability to work in a collaborative and independent work environment with minimal supervision.
• Remain calm and receptive in fast-paced situations.

Qualifications

• Associate’s 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.).

Physical Requirements

• Ability to travel approximately 20% as necessary to other facilities.
• 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.

We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class. Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.