Job Description:
- Our client is looking for a 8-15 year experienced engineer with hands on experience with automated vision systems as they move forward into the SAT phase of getting this system up and running. Ideal candidate comes with experience installing, troubleshooting, commissioning, qualifying and project management.
General Management:
- Manage schedule (proficient with MS Project)- the individual should be a multitasker and have experience working and communicating cross functionally between multiple departments
- Understand how to comply with GMP and GDP
- Proficient in people management and conflict resolution
- Able to manage multiple contactor trades and commissioning/validation activities
Construction:
- Provide necessary on-site supervision of installation of equipment and tie-in connections to utilities
- Establish and update construction schedule
- Coordinate contractors for mechanical work, civil work, electrical work, etc.
- Tracking of delivery for the equipment
- Planning for each contractor discipline to make sure to keep on track with the timeline; communicating with the manager to update timelines
- Perform inspection of installation to ensure quality of work matches the design and site specification
- Reviewing change orders created during the installation of the equipment
- Leading project or progress meetings with contractors to report on progress
- Managing a punch list for any work not done to standards or remaining items; establishing a schedule for insuring punch list items are completed in a timely manner
- Oversee all trade contractor’s safety programs and practices are being followed
Commissioning/Qualification:
- Background in commissioning and qualification of equipment, prefer automated packaging equipment for Vial and Syringe Line Filling operations. Client uses a version of Vision System called Optel
- Follow GDP when filling out commissioning and/or qualification documentation
- Able to troubleshoot equipment during commissioning and/or qualification by knowing who to contact
- Managing a punch list for any commissioning activities that are not able to be executed for any reason
- Able to draft documentation for a Change Control process, specifically Technical Evaluations and Test Plans
Skills:
C&Q, Project Management, Fill, Packaging, SAT, FAT, Commissioning, Qualification
Education:
Chemical Engineering Degree Preferred. B.S. Degree in engineering is a hard requirement. (ChemE preferred, but will take BSME, or BSEE).
On-Site: Capital Equipment Engineer (234437)
