Process Engineer

JOB DESCRIPTION:

The candidate for this position will be responsible for monitoring the operations of our systems, including quality and compliance. The candidate should also be able to recommend improvements to the process through the tracking of metrics and reporting of data. The candidate should definitely have strong technical abilities in order to succeed in this role. Please note that we are unable to sponsor applicants requiring work authorization or visas for the positions currently available. We kindly request that only candidates who already possess the legal right to work in the United States apply for consideration.

Responsibilities

1. Manufacturing Support

• Develop technical knowledge on manufacturing equipment and processes
• Support resolution of major equipment breakdowns and quality issues in the suites
• Provide SME support to Manufacturing and other departments for the design and operation of process equipment.
• Conduct troubleshooting and technical analyses on manufacturing equipment and processes including PI data analyses, CIP/SIP circuit review, MOC analyses, flow path analyses, etc.

2. Projects

• Planning and execution of plant projects involving equipment changes and process improvements.
• Execute commissioning protocols (installation, operation, CIP/SIP, wet testing) with support and guidance from supervisor

3. Documentation

• Review/revise Engineering and Manufacturing related SOP’s, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, error prevention activities, etc.
• Complete engineering review/approval of batch records
• Initiate EDCRs for updates to Engineering documents including engineering drawings
• Author commissioning protocols (installation, operation, CIP/SIP, wet testing).

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