The Commissioning. Qualification and Validation Engineer is responsible for providing engineering support to various areas, including clean-in-place systems, and manufacturing support equipment. This engineer will be involved in Commissioning and Qualification (C&Q) activities.
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)
- Execution of Commissioning and Qualification.
- Provide process engineering support for Clean In Place systems in pharmaceutical process equipment
- Execution of Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and development of final reports.
- Assist the project lead in the delivery of scheduled executions and other scoped items within prescribed timeline.
- Assist the project lead in the delivery and project management processes required to complete the project within the timeline and budge.
- Promote cGMP and regulatory compliance into assigned projects.
- Document, monitor, and report on project deliverables
- Manage project documentation such as protocols, data packages, reports, calibration certificates, and process trends.
Qualifications- BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience
- Minimum 1 year of experience in Commissioning and Qualification.
- 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.
- Ability to pivot mindset and project goals to assist in compliance troubleshooting.
- 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/efficiently.
- Ability to relate with people at all levels within an organization, including diverse cultures.
At Hyde Engineering + Consulting, we are an employee-owned firm comprised of industry experts looking to make a meaningful impact for our biopharmaceutical and pharmaceutical clients around the world. We are uniquely positioned in the marketplace to provide solutions to support full-cycle project delivery starting with an optimized cleaning program developed by Hyde’s ISO-90001 certified CORE Lab. This work segues into state-of-the-art engineering, commissioning and qualification of facilities and equipment.
As we continue to grow our operations around the world, we are hiring engineers and consultants who take ownership in their professional work as well as ownership in the long-term success of Hyde. Our owners embody an entrepreneurial spirit, have diverse perspectives and a passion for learning while simultaneously cultivating lasting client relationships.
You will find these values reflected in our company:
- Family
- Integrity
- Friendship
- Wisdom
- Adventure
Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.
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