C & Q Engineer - Parts Washers

The Commissioning & Qualification Engineer is responsible for providing engineering support to various areas, clean-out-of-place, parts washers, cleaning validation of parts washers, 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). SHIFT WORK REQUIRED Responsibilities Commissioning and qualification of clean-out-of-place, parts washers. Cleaning Validation of parts washers. 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 A minimum of 3+ years pf pharmaceutical manufacturing experience or in a GMP environment. Three or more years’ experience with Commissioning, Qualification and Validation of parts washers and working knowledge 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 BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience 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 as needed 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. #LI-JS1 #LI-Hybrid #Associate