Current Opportunities
Please submit inquiries to info@hbsage.com
Open Positions
Hummingbird Sage is hiring for an on-site Consulting Role located in North Carolina's Research Triangle. The project duration will be a minimum of 6 months.
Validation Engineer
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Duties and Responsibilities
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Perform validation activities for equipment and instrument systems (i.e. Simple Direct Impact and No Impact) that include drafting, executing, reviewing, and approving quality documentation. This includes but may not be limited to:
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Validation Project Plans
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System Impact Assessments (SIAs)
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User Requirement Specification (URS)
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Commissioning Protocols and Reports
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Installation and Operation Qualification (IOQs)
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IOQ Summary Reports
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Investigations
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Risk Assessments
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Requirements Traceability Matrices (RTMs)
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Responsible for on-boarding vendors, where applicable.
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Responsible for managing day to day validation activities to ensure projects and assignments are completed on time with limited supervision.
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Act as the department’s coordinator for equipment investigations.
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Identify, document, and investigate protocol deviations with cross functional teams as required to resolve and close out deviations.
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Prepare, review, and approve relevant change controls, CAPAs, and/or investigation reports supporting validation activities.
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Provide equipment and instrument technical support for equipment preventive maintenance and repairs.
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Work with cross-functional teams to complete validation projects, tasks, and investigations.
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Ensure validation systems align with corporate and departmental objectives and requirements and that they meet compliance standards as defined by the relevant regulations.
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Align with industry recommendations and best practices.
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Communicate and ensure agreed upon changes are applied to validation systems, as appropriate.
Qualification
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Bachelor’s Degree in Engineering, life sciences or technical disciple required or equivalent experience.
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Applicants must be authorized to work in the U.S. without sponsorship
Experience
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3 to 5 years of experience in equipment and instrument validation
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Experience using Microsoft products (Word, Excel, PowerPoint)
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Experience using Smartsheet
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Knowledgeable of cGMP and 21CFR and Annex 1 regulations
Knowledge, Skills, Abilities
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Outstanding attention to detail and organizational skills.
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Self-starter, independent and dependable.
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Ability to work effectively with minimal supervision.
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Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented.
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Effective prioritization skills.
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Requires discretion, great listening skills and independent judgment.
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Highly effective verbal and written communication skills.