Commissioning Qualification Engineer

The  Commissioning & Qualification Engineer  is responsible for providing engineering support to various areas, including media preparation, harvest capture and clarification, buffer preparation, clean-in-place systems, and manufacturing support equipment. This engineer will be involved throughout the project lifecycle, including Factory Acceptance Testing (FAT) and Commissioning and Qualification (C&Q).

Responsibilities

• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Perform systems and P&ID Walkdowns, commission equipment, and provide Equipment Turnover Packages (ETOPs)
• Spray coverage testing, cleaning verification swabbing, and sample submission practices
• Provide process engineering support for clean water systems, CIP, SIP and pharmaceutical process equipment
• Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports
• Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
• Promote cGMP and regulatory compliance into assigned projects
• Review and modification of standard operating procedures (SOPs) for various equipment
• Document, monitor, and report on project deliverables
• Manage project documentation such as protocols, reports, calibration certificates, and process trends.

Desired Skills and Experience

Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To read more about Hyde's culture and benefits, visit our website :   www.hyde-ec.com

You will find the following values reflected in our company :

Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.

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