Commissioning Qualification Engineer

The Commissioning & Qualification Engineer is responsible for providing engineering support to various areas, including process equipment, cleaning systems, fill/finish equipment, isolators, utilities, HVAC, monitoring systems and facilities. This role will be involved throughout the project lifecycle, including Factory Acceptance Testing (FAT), construction support, and Commissioning and Qualification (C&Q).

• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Perform several activities on clean water systems, compressed gases systems, CIP, mixing and storage vessels, distribution systems, and other pharmaceutical process equipment. Major activities include the following:
• Perform systems and P&
• Write and execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports
• Commission and qualify equipment, and provide Equipment Turnover Packages (ETOPs)
• Provide process engineering support for clean water systems, compressed gases, CIP, and pharmaceutical process equipment
• 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 and be able to report findings to clients and vendors

• BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience
• Experience with pharmaceutical manufacturing
• Ability to create an environment of trust, compliance, continuous improvement and learning
• Demonstrated ability to manage multiple priorities with aggressive timelines
• Effective written communication utilizing GDP; effective oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately
• Ability to relate with people at all levels within an organization, including diverse cultures
• Willingness to travel within the United States as needed

Salary range: $75-110K annually, DOE

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