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Senior Validation Engineer
4 weeks ago
Gahagan & Bryant Associates Inc Broomfield, United StatesSenior Validation Engineer · COMPI is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior Validation Engineer to ...
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Senior Validation Engineer
3 weeks ago
Gahagan & Bryant Associates Inc Broomfield, United StatesSenior Validation Engineer · COMPI is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior Validation Engineer to ...
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Verification & Validation Test Engineer
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Verification & Validation Test Engineer
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Director of Validation Engineering
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Computer Systems Validation Engineer II
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Process Validation Engineer III
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Verification & Validation Test Engineer
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JSat Automation Inc Concord, United StatesJob Description · JSat Automation is hiring an Automation Support and Validation Engineer with 0-2 years of experience. We are looking to train someone on the following below. · • Design, develop and support manufacturing control systems in support of process operations. · • Prov ...
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Computer Systems Validation Engineer III/IV
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PCI Limited Bedford, United StatesLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. · We are PCI. · Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to ...
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Sr. Product Manager
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Mechanical Engineering Manager
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Roman Health Pharmacy LLC Broomfield, United StatesPlease Note: · To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protected individuals as defined by 8 U.S.C. 1324b(a)(3)), or el ...
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Senior Flight Software Engineer I
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Senior Mechanical Engineer II
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Engineer I Ground Systems Engineer
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Systems Engineer
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Senior Mechanical Engineer II
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Systems Engineer II System Traceability Lead
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Advanced Analog Electrical Engineer
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Project Engineer
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Senior Validation Engineer - Broomfield, United States - GBA
Description
COMPI is a full service engineering contracting and consulting servicescompany with a life sciences division specializing in pharma, biotech,API, Medical Device and laboratory facilities.
Responsibilities:
Support Client commissioning / validation for facility, utility,equipment, cleaning and process validation projectsPrepare and execute commissioning / validation lifecycle documentsParticipate in any stage of clinical or commercial production including greenfield construction, facility renovation, new product development,product launch, or product/process upgradeWrite summary reports for validation and qualification protocolsSupport project milestones, priorities and deadlinesWrite opera ting procedures for technical equipment and practices andproceduresPerform system and process risk assessments and analysesSchedule and coordinate protocol execution with other departments includingmanufacturing, facilities and project managementDevelop project specific validation plans and strategyAble to manage and execute multiple projects to meet client s prioritiesProvide a practical approach to problem solvingIndividuals must represent COMPI at client sites and interact confidently withclients, contractors, management and peers
Requirements:
Bachelor s degree in a related life sciences or requisite industry trainingand experience5 10 years GMP experienceAseptic process experience preferredCritical utility experience preferredAbility to converse about scientific mattersAbility to work independently or in collabora tion with othersIn depth understanding and application of validation principles, concepts,practices and standardsProficient in current Good Manufacturing Practices and other applicableregulationsExperienced with all pertinent industry best practices (e.g., ISPE)including development and execution of all applicable system life cycledeliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit,Integration, User Acceptance testing, FAT, SAT, Validation Planning,IQ, OQ, PQ, Final Validation Summary ReportDemonstrated expertise in at least one aspect of system qualification andregulatory compliance (e.g.
On the job tr aining will be provided by the validation team and manager,and through industry training and certification courses, both online and inperson.
All candidates must be legally eligible to work in the United States.Just be willing to travel regionally and / or nationally throughout the U.S.
We are an equal opportunity employer M/F/D/V
COMPI does not accept unsolicited resumes from recruiters / third parties.
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