Description:
Ideal candidate: B.S. 2-3+ YOE troubleshooting equipment.
The Engineer, Downstream will lead the troubleshooting and vendor support for a wide variety of process equipment that supports manufacturing.
Nice to have: PNID experience
Scope includes a wide range of devices such as Cleaning Systems (Autoclave, Glassware Washers, Dryers, CIP/COP), Single Use Systems (TFF, VI/VF, Chrom). SS Systems (TFF, VI/VF, Chrom, Columns, Tanks, Pumps), and misc equipment. The qualified candidate will work with the manufacturing and engineering team to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.
Responsibilities: - Work cross-functionally with individuals and project teams in Engineering, Instrumentation, and Manufacturing. Determine technical coverage and proper integration of different subsystems. Provide deep technical assistance for other support staff and operators using equipment.
Skills: BS in Engineering, Biotech, Chemistry, or Equivalent and previous experience in a biotech/pharmaceutical industry with focus on usage and/or process equipment of specified equipment - 2 years current experience with processes equipment troubleshooting and GMP procedures. Strong background in troubleshooting, root cause analysis, and vendor coordination. Must be capable of working on multiple projects in a deadline driven environment.
Top 3 Must Have Skill Sets:
GMP / FDA Background
Biotech / Pharma Equipment Troubleshooting Background
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