|Date Posted||May 14, 2021|
|Address||645 Science Drive|
The GMP Facilities Engineer is recognized as a strong technical contributor within the Operations Team supporting the facilities & utilities required for cGMP API manufacturing. This position will support the sites in Madison and Verona, WI for facility systems and utilities, including purified water, air handling systems, heat/cooling systems, electrical, and other supporting equipment and infrastructure. The GMP Facilities Engineer oversees tasks for coordinating activities with contractors and with other departments including Manufacturing, Maintenance, Engineering, Quality Assurance, Validation, Quality Control, Project Management, and Process Development. In addition, the GMP Facilities Engineer may also interface with customer personnel, auditors, and regulatory authorities, as needed, to communicate system design, qualification, and status of facility systems and utilities.
- Support activities associated with site’s infrastructure and utilities, including but not limited to, operation, qualification, preventative maintenance, change control, shut-down activities, risk assessments, leading investigations, trouble-shooting, root cause analysis, and CAPA implementation
- Ensure planned and unplanned work is prioritized and managed closely to minimize equipment downtime and disruptions to Operations’ schedule
- Ensure all activities are performed in accordance with safety, quality, cGMP, and applicable regulatory requirements
- Ability to understand regulatory requirements such as ICH Q7, 21CFR Part 210 and 211, 21CFR Part 600, and EMA guidelines as they relate to utilities and pharmaceutical manufacturing facilities
- Identify, qualify and oversee contractors needed to perform on-site work, including adherence to safety and quality site standards and procedures.
- Assist in factory and site acceptance testing for new equipment
- Support equipment commissioning, qualification, and validation activities related to GMP manufacturing
- Write, review and/or assist in the development of Manufacturing, Facility or Equipment Operating Procedures
- Generate and/or review user requirement specifications for utilities, facility, and processing equipment
- Identification, recommendation, and implementation of replacement-in-kind, new or improved equipment and/or systems in support of existing utilities as well as new or existing manufacturing processes
- Aptitude to read and interpret P&IDs, equipment manuals, and electrical/mechanical drawings
- Work with other disciplines to ensure the necessary details related to the systems are fully coordinated
- Research equipment providers and make recommendations and selections based on project requirements and business needs
- Drive continuous improvement to support customer and regulatory expectations
- Travel Requirements: Minimal travel may be required for factory acceptance testing of equipment and/or best practice sharing between sites.
- Physical Requirements: This position requires occasional lifting of no more than 35 lbs and pushing heavy vessels/ equipment.
- Work Schedule: Must be able to work independently on a variety of shifts as needed to support utility operations.
Who you are:
- Education: B.S. in an Engineering discipline (preferably Chemical or Mechanical Engineering), or equivalent degree
- Minimum of 3+ years relevant industrial plant engineering experience in a cGMP pharmaceutical manufacturing setting.
- 3+ years of Engineering background with knowledge of utilities, and general pharmaceutical plant infrastructure.
- 1+ years of experience of modeling facility systems Aspen Hysys or UniSim or 1+years of general programming experience
- 3+ years of experience with FDA, EMA, and other regulatory standards and requirements for facility and utility processes
- To succeed in this role, you should have “hands-on” experience in a GMP manufacturing environment.
- Strong technical engineering skills, demonstrated ability to work within a cross-functional team, and excellent interpersonal and team-building skills.