Facility/Utility Engineer

• The primary responsibility for this role is ensuring assigned equipment/systems are fit for purpose and ready for use by manufacturing.
• Additional responsibilities include investigating and assessing unplanned equipment related events, managing planned equipment changes, and executing/supporting small projects.
• The role will coordinate with a cross functional team including Manufacturing, Process Engineering, Maintenance, System Owners, Automation, SHE, and Quality Assurance.

• B.S, M.S, Ph.D or advanced degree in engineering preferred
• At least 6 years of experience in the industry and/or academics (including advanced studies)
• Technical understanding of autoclaves sterilization processes, parts washers, clean in place (CIP) skids, bioreactors, centrifuges, and/or process analytical systems is preferred.
• Sound knowledge of current Good Manufacturing Practices(cGMPs) as they apply to biopharmaceutical manufacturing facilities or equivalent regulation
• Familiarity with reliability engineering principles and techniques preferred.
• General knowledge of bio-tech related unit operations
• Experience with automated systems, trend analysis, and troubleshooting
• Uses extensive operational knowledge and cross-functional experience to solve problems
• Performs work under limited supervision; establishes own work priorities and timelines
• Provides guidance and coordinates the activities of team members as needed
• Exercises independent judgment and discretion in their assigned areas of responsibility
• Represents our organization as primary contact for initiatives and projects

Ideal Qualities:

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

• Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
• Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
• Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others. 
• Understands worldwide regulations and phase appropriate applications
• Draws insights from projects and supplemental research to help drive new and existing growth. 
• Ensures activities are efficient, optimized, and client-centric. 
• Highly motivated and organized, solutions oriented leader
• Curious and adaptable - has the ability to transform knowledge into actionable activities
• Able to produce results in a fast paced, collaborative environment