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Downstream CQV Engineer
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United Pharma Technologies Inc
Holly Springs, NC (In Person)
Full-Time
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Job Description
Downstream CQV Engineer at United Pharma Technologies Inc Downstream CQV Engineer at United Pharma Technologies Inc in holly springs, North Carolina Posted in 2 days ago.
Perform equipment walkdowns, P&ID verification, mechanical completion support, shakedowns, startup activities, and field troubleshooti ng.
Execute IQ, OQ, and PQ protocols, and assist with qualification summary reports and supporting documentati on.
Support commissioning and qualification of downstream process systems, includi ng:
Buffer hold ta nksUltrafiltration (UF) syst emsLow-pressure chromatography syst emsChromatography colu mnsProcess pu mpsLarge-scale stainless-steel process equipm entUtilize DeltaV during equipment commissioning and qualification activiti es.
Identify, investigate, and resolve equipment and process issues independently during field executi on.
Support mechanical completion, system turnover, and operational readiness activities throughout the project lifecyc le.
Ensure compliance with GMP regulations, site safety standards, and Lockout/Tagout (LOTO) procedures while working in active manufacturing are as.
Collaborate with Engineering, Automation, Operations, Validation, and Quality teams to achieve successful system startup and project mileston es. Required Qualificat ions5-10 years of experience in Commissioning, Qualification, Validation (CQV), Process Engineering, or related field execution within a biopharmaceutical manufacturing environm ent.
Hands-on experience supporting drug substance manufacturing equipment, preferably in downstream process ing.
Strong experience with stainless-steel process equipment, including tanks, pumps, ultrafiltration systems, chromatography equipment, and associated downstream unit operati ons.
Proven experience perform ing:
Equipment walkd ownsP&ID verifica tionStartup sup portShaked ownsField troubleshoo tingWorking knowledge of
Experience using DeltaV in support of equipment commissioning and qualificat ion.
Ability to work independently with minimal supervision while resolving technical issues in the fi eld.
Strong understanding of GMP manufacturing requirements and CQV best practi ces.
Excellent communication and cross-functional collaboration ski lls. Preferred Qualifica tionsExperience with downstream processing operations, inclu ding:
Buffer prepar ationUltrafiltration (UF)Low-pressure chromatog raphyChromatography co lumnsLarge-scale stainless-steel manufacturing sy stemsExperience with KNEAT or other electronic validation documentation sys tems.
Experience supporting greenfield facilities, site expansions, or manufacturing startup proj ects.
Familiarity with mechanical completion documentation, system turnover packages, and startup readiness activi ties.
Upstream biopharmaceutical experience will also be considered for candidates with strong stainless-steel equipment, DeltaV, field execution, and qualification exper tise.
Process Engineers with significant biopharmaceutical equipment experience who are interested in transitioning into a CQV field execution role are encouraged to a pply.
Type:
full-timeJob Description:
Job Title:
Downstream CQV Engineer Location:
Holly Springs, NC (Onsite)Duration:
Long-Term Contract Position Overvie wOur client, a leading biopharmaceutical contract manufacturing organization, is expanding its Downstream Commissioning, Qualification, and Validation (CQV) team to support large-scale drug substance manufacturing operations. This is a hands-on, field execution role focused on commissioning, startup, qualification, and troubleshooting of downstream process equipment in a GMP manufacturing environment The ideal candidate will have strong downstream biopharmaceutical experience, extensive knowledge of stainless-steel process equipment, and the ability to independently execute CQV activities in the field. Candidates should be comfortable performing equipment walkdowns, startup support, shakedowns, troubleshooting, and qualification execution while collaborating with cross-functional engineering and manufacturing team s. Key Responsibilit iesExecute commissioning, qualification, and validation (CQV) activities for downstream drug substance manufacturing equipme nt.Perform equipment walkdowns, P&ID verification, mechanical completion support, shakedowns, startup activities, and field troubleshooti ng.
Execute IQ, OQ, and PQ protocols, and assist with qualification summary reports and supporting documentati on.
Support commissioning and qualification of downstream process systems, includi ng:
Buffer hold ta nksUltrafiltration (UF) syst emsLow-pressure chromatography syst emsChromatography colu mnsProcess pu mpsLarge-scale stainless-steel process equipm entUtilize DeltaV during equipment commissioning and qualification activiti es.
Identify, investigate, and resolve equipment and process issues independently during field executi on.
Support mechanical completion, system turnover, and operational readiness activities throughout the project lifecyc le.
Ensure compliance with GMP regulations, site safety standards, and Lockout/Tagout (LOTO) procedures while working in active manufacturing are as.
Collaborate with Engineering, Automation, Operations, Validation, and Quality teams to achieve successful system startup and project mileston es. Required Qualificat ions5-10 years of experience in Commissioning, Qualification, Validation (CQV), Process Engineering, or related field execution within a biopharmaceutical manufacturing environm ent.
Hands-on experience supporting drug substance manufacturing equipment, preferably in downstream process ing.
Strong experience with stainless-steel process equipment, including tanks, pumps, ultrafiltration systems, chromatography equipment, and associated downstream unit operati ons.
Proven experience perform ing:
Equipment walkd ownsP&ID verifica tionStartup sup portShaked ownsField troubleshoo tingWorking knowledge of
IQ, OQ, PQ
execution and qualification documentat ion.Experience using DeltaV in support of equipment commissioning and qualificat ion.
Ability to work independently with minimal supervision while resolving technical issues in the fi eld.
Strong understanding of GMP manufacturing requirements and CQV best practi ces.
Excellent communication and cross-functional collaboration ski lls. Preferred Qualifica tionsExperience with downstream processing operations, inclu ding:
Buffer prepar ationUltrafiltration (UF)Low-pressure chromatog raphyChromatography co lumnsLarge-scale stainless-steel manufacturing sy stemsExperience with KNEAT or other electronic validation documentation sys tems.
Experience supporting greenfield facilities, site expansions, or manufacturing startup proj ects.
Familiarity with mechanical completion documentation, system turnover packages, and startup readiness activi ties.
Upstream biopharmaceutical experience will also be considered for candidates with strong stainless-steel equipment, DeltaV, field execution, and qualification exper tise.
Process Engineers with significant biopharmaceutical equipment experience who are interested in transitioning into a CQV field execution role are encouraged to a pply.