Senior Validation Engineer

4 weeks ago

Broomfield, United States GBA Full time

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. We are seeking an experiencedSenior Validation Engineer to join our growing team. COMPI differentiatesitself through an integrated approach to engineering, constructioncommissioning and validation. 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., EMEA, GCP, GLP, GMP, QSR) andinternal requirements employing regulatory guidance and industry standardsExcellent written communication skills with emphasis in technical writingProficient in Microsoft Word, Excel, Power Point and ProjectsSalary range is 85-175K, depending on experience level 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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