Facilities Engineering Specialist

Responsibilities

• Serve as the process owner and point of contact for the Contamination Control Program.
• 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.

Qualifications

• Associates Degree in Chemistry, Biology, Engineering or related field, or equivalent experience.
• 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.
• 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.