Lead CQV Engineer

6 days ago

Syracuse, New York, United States Pharmatek Consulting Full time

Location: Onsite Syracuse NY Contract Duration: 12+ Months, Potential to go longer Role will drive the CQV strategy for the project, leading a team of engineers to successfully deliver deliverablesAuthor, edit, and execute technical commissioning, qualification and validation documentation for standard equipment/systems/ softwareAdherence with project schedule for all assigned activitiesMaintaining clear, detailed records for qualification and validationDocumenting impact and risk assessments as part of a teamMaking recommendations for design or process modification based on test results when executing test scriptsGeneral understanding of capital equipment implementation and process knowledgeUnderstanding validation documentation from URS to Summary Reporting RequirementsMust be willing to work onsite in Syracuse, NYMinimum of 12 years of experience in CQV activities specific to a broad range of facility, utility, and process equipment including autoclaves, fillers, reactors, isolators, freezers, etc.Extensive experience authoring and executing IQ/OQ/PQ activitiesAbility to write sampling protocols and develop protocol templatesSpecific qualification experience with Autoclaves, TFF Skid, chrome skid (preferred)Experience qualifying Single User Reactors and Single Use Mixers (preferred)Experience developing and executing mixing studiesExperience with clean room developing and/or executing EMPQ protocolsKnowledge of Process Automation and equipment testingExperience using Delta VBachelor's degree (minimum) in hard sciences, preferably Chemical EngineeringProficiency in using PC and Microsoft Office toolsOutgoing personality with strong ability to communicate effectively with peers in clear, concise termsAbility to lead a team of engineersStrong problem -solving and critical thinking skillsExcellent organizational and time management skillsStrong attention to detailGMP and Good Documentation Practice knowledgeStrong interpersonal skills and clear communication capabilitiesExperience with and tolerance for high levels of challenge and changeProven attention to detail and organization in project workCapable of working on assigned tasks without mentorship

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