Installation Verification Engineer Position Available In Wake, North Carolina

Job Description Our client in the Raleigh-Durham area is looking for a CQV Installation Verification Engineer to join their team in Raleigh-Durham. The engineer will support drug substance manufacturing buildings and help support installation verification and CQV activities for upstream, downstream, and utilities equipment. Equipment includes, but not limited to buffer/media preparation, buffer hold, chromatography skids and columns column packing, ultrafiltration/diafiltration, filtration skids, transfer stations, harvest/centrifugation, seed and production bioreactors, SIP/CIP. Plan, develop, and execute CQV and IV protocols Develop protocols, reports, and validation plans in the Kneat electronic validation system to support project milestones. Support CQV from design phase, acceptance testing, startup, qualification, to final handover to operations. Liaise with EPCM contractor in relation to construction readiness and schedule for Process Equipment Systems Perform and support field walkdowns for systems. Support CQV review, aligning with Turnover Group in relation to review and approval of Vendor and Contractor Turnover Packages within scope. Support punchlist closure and verification pre-Mechanical Completion and during the CQV execution phase for Process Equipment systems. Liaise with CQV Project Management and Scheduling in relation to schedule creation and management for all Process Equipment, ensuring all correct predecessors and successors are in place. Ensure Commissioning readiness of all Process Equipment Systems to support Equipment Start-up and IOQ Testing. Support Pre-Startup Safety Review and Set to Work field execution and guide CQV Team through Start-up exercise in a safe and controlled manner. Support CQV Process with engineering documentation management system and ensure full traceability at all times for all systems. Liaise with all Project Groups (Design/Construction Management /CQV/Automation/Process/SMEs/Operations/Maintenance/Project Management/Quality) to ensure all Process Equipment systems are managed appropriately for the entire Project Lifecycle. Liaise with CQV Document Generation Support in relation to generation and approval of; DQ/Design Reviews /Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols Run Weekly CQV Process Equipment to ensure status updates are provided to cross-functional team. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com . To learn more about how we collect, keep, and process your private information, please review

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Skills and Requirements Must Haves:

Bachelor’s Degree in Engineering or related field

• 3+ years of experience supporting the pharmaceutical industry
• 1+ years of CQV and IV (Installation Verification) experience in a startup environment
• 1+ years of experience with upstream equipment and processes such as buffer prep, media prep, buffer hold, chromatography skis, SIP, CIP, ultrafiltration, bioreactors etc.
• Ability to operate within a fast paced team based environment

Pluses:

• FAT / SAT

  experience

• Process Engineering, Chemical Engineering or Mechanical Engineering Background null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.