About This Role
This engineering role provides support across various manufacturing areas, focusing on process equipment improvements, technological advancements, capital projects, cost improvements, facility maintenance, and safety and environmental regulation. The role involves leading critical and plant utility projects from inception to completion and collaborating with functional department leaders to understand equipment capability and capacity needs.
Responsibilities
- Support safety initiatives and promote individual accountability for safety within the Plant Engineering Department
- Conduct all activities in accordance with cGMP, EH&S, and the site quality systems
- Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning & qualification
- Coordinate design, procurement, installation, engineering start-up, and validation activities of new equipment and systems including documentation of IQ/OQ protocols, executions, and summary reports
- Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout
- Design and execute engineering runs to test equipment or to troubleshoot problems
- Perform process/equipment investigations and prepare appropriate documentation/report (deviations, NCs, CAPA)
- Identify and resolve problems in a timely manner; gather and analyze information skillfully; develop alternative solutions; work well in group problem solving situations
- Provide technical support for the user with respect to investigations, re-occurring problems, required modifications, optimizations and Continuous Improvements
- Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform Factory/Site Acceptance Testing
- Execute good Engineering practices for new equipment/Systems/utilities as applicable
- Procure new equipment, create and maintain the appropriate engineering records including equipment records and manuals, drawings and diagrams, inspection reports per Good Engineering policies
Requirements
- Bachelor
- 4-7+ years
- Strong understanding of technical project management, Good Engineering Practices, reliability, and Lean Principles
- Strong organization, interpersonal, oral and good written communication skills
- Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharma/medical device processes
- Proficiency with standard software applications, including Microsoft Office Suite
Nice to have:
- Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices
