Commissioning Qualification Engineer in Boulder

Job DescriptionThe 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).\n
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Responsibilities\n

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• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors

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• 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:

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• Perform systems and P&ID Walkdowns

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• Write and execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports

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• Commission and qualify equipment, and provide Equipment Turnover Packages (ETOPs)

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• Provide process engineering support for clean water systems, compressed gases, CIP, and pharmaceutical process equipment

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• Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.

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• Promote cGMP and regulatory compliance into assigned projects

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• Review and modification of standard operating procedures (SOPs) for various equipment

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• Document, monitor, and report on project deliverables

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• Manage project documentation such as protocols, reports, calibration certificates, and process trends and be able to report findings to clients and vendors

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Desired Skills And Experience\n

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• BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience

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• Experience with pharmaceutical manufacturing

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• Ability to create an environment of trust, compliance, continuous improvement and learning

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• Demonstrated ability to manage multiple priorities with aggressive timelines

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• Effective written communication utilizing GDP; effective oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately

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• Ability to relate with people at all levels within an organization, including diverse cultures

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• Willingness to travel within the United States as needed

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Salary range: $75-110K annually, DOE\n
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\n 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\n
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\n Hyde Engineering + Consulting is an equal opportunity, affirmative action employer\n
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