Commissioning Qualification Engineer

2 weeks ago

San Francisco, United States HYDE ENGINEERING + CONSULTING Full time

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
  • BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience
  • Understanding of a variety of equipment including: process vessels, chromatography skid/column, UF/DF skid, centrifuge, CIP, buffer preparation, glass washers and parts washers
  • 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 and 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

You will find the following values reflected in our company:

  • Family
  • Integrity
  • Respect
  • Wisdom
  • Adventure

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

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