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).
Responsibilities
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, affirmative action employer
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 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
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, affirmative action employer
Commissioning Qualification Engineer in Boulder at Hyde Engineering + Consulting
This position is listed as full time and onsite. It was posted yesterday.