Validation Engineer

The Commissioning & Qualification Engineer is responsible for providing engineering support to various areas, including process vessels, chromatography skid/column, lyophilizer, UF/DF skid, CIP, clean water skid, compressed gas distributions, solvent charging and handling systems, buffer preparation, glass washers and manufacturing support equipment. This engineer will be involved throughout the project lifecycle, including Factory Acceptance Testing (FAT), construction support, and Commissioning and Qualification (C&Q).

Responsibilities

• 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&ID Walkdowns
• 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
• 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
  
  
  

Desired Skills And Experience

• BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience
• Experience in construction safety and manufacturing safety
• Ability to work on complex or undefined problems and quickly identify and address critical issues
• 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
  
  
  

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

Hyde Engineering Consulting is an equal opportunity employer.

Associate