The Commissioning. Qualification and Validation 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).
- 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)
- Cleaning verification swabbing, and sample submission practices
- Provide process engineering support for clean water systems, CIP, COP, SIP, CTU and pharmaceutical process equipment
- Write and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), cycle development protocols including development of final reports and validation protocols including final reports
- Assist the project lead in the delivery of scheduled executions and other scoped items within prescribed timeline.
- Assiste 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
- Review and modification of standard operating procedures (SOPs) and validation protocols for various equipment
- Document, monitor, and report on project deliverables
- Manage project documentation such as protocols, data packages, reports, calibration certificates, and process trends.
- 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, CTU’s, CIP, buffer preparation, sonicators, 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
- 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
- Willingness to travel as needed
Since 1993, Hyde E+C has worked as an integral part of project teams for clients and equipment vendors in the pharmaceutical and biopharmaceutical industries, resulting in the successful construction, commissioning and validation of facilities and equipment. As a member of the Hyde team, you will be responsible for providing state-of-the-art custom solutions to leaders in our industry. As we continue to grow our operations globally, we strive to hire the best talent—men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits.
You will find the following values reflected in our company:
Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.